510(k) · Cleared
Recalled · Class II · 2014Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · OWB Interventional Fluoroscopic X-Ray System
Cleared on Sep 16, 2005 as substantially equivalent to K974715 (GE Medical Systems, 1998) and 3 other predicates after a 14-day review. Its family tree reaches back 5 generations to 1989. 74 later devices descend from it. It has been recalled 50 times.
- Decided
- Sep 16, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 50
- Predicates
- 4
Its longest line of descent runs back 5 generations to K890348 (1989). 14 ancestors in all. 74 later devices descend from it, 8 citing it directly.
- Root · 5 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 4 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 3 generations backK022322 Innova and Innova 2000 SGe Medical Systems, Inc. · 2002 · Recalled
- 2 generations backK031637 Innova 3100GE Medical Systems · 2003 · Recalled
- 1 generation backK050489 Innova 2100Ge Medical Systems, LLC · 2005 · Recalled
- This deviceK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005
- Descendant · cites it directly · 47 of its ownK060259 Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC · 2006 · Recalled
- Descendant · 2 generations on · 23 of its ownK081582 Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C · 2008 · Recalled
- Descendant · cites it directly · 22 of its ownK061163 Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova…Ge Medical Systems, LLC · 2006 · Recalled
- Descendant · cites it directly · 21 of its ownK101868 Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C · 2010
- Descendant · 2 generations on · 20 of its ownK120073 Infx-8000V withToshibamedical Systems Corporation · 2012 · Recalled
Showing 5 of 74 descendants. See all descendants
Descendants cleared per year
2006high 10 (2018) · low 0 (2007)2026
Most influential descendants
Showing 5 of 74 · See all- K060259Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC · 2006 · cites it directly47descendants
- K081582Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C · 2008 · 2 generations on23descendants
- K061163Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ…Ge Medical Systems, LLC · 2006 · cites it directly22descendants
- K101868Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C · 2010 · cites it directly21descendants
- K120073Infx-8000V withToshibamedical Systems Corporation · 2012 · 2 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −4 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −3 | K022322 | Innova and Innova 2000 S | Ge Medical Systems, Inc. | 2002 | 7 |
| −2 | K031637 | Innova 3100 | GE Medical Systems | 2003 | 25 |
| −1 | K050489 | Innova 2100 | Ge Medical Systems, LLC | 2005 | 27 |
| 0 (this device) | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | — |
| +1 | K060259 | Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121 | Ge Medical Systems, LLC | 2006 | 4 |
| +2 | K081582 | Infx-8000V, Infinix-Cfi and Infinix Vfi | Toshiba America Medical Systems, In.C | 2008 | 1 |
| +1 | K061163 | Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova… | Ge Medical Systems, LLC | 2006 | 38 |
| +1 | K101868 | Infinix-I Interventional Angiography System Model Infx-8000V | Toshiba America Medical Systems, In.C | 2010 | — |
| +2 | K120073 | Infx-8000V with | Toshibamedical Systems Corporation | 2012 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 10 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OWB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K974715 | Advantage 3D XRSummary page 1…for Innova 4100 Innova 4100'°, Innova 3100, Innova 3100'@ , Innova 2100'® devices Is substantlally equivalent to the currently marketed software option Advantage 3D XR (K974715). The GE Healthcare InnovaSpin optlon for Innova 4100, Innova 4100'%, Innova .3100, Innova 3100'® devices is substantially equnv… | 1998 |
| * | K050489 | Innova 2100Summary page 1…%, Innova .3100, Innova 3100'® devices is substantially equnvalent to the currently marketed InnovaSpin optuon of the Vascular Angiographic system Innova 2100 (2100-1Q) (K050489). The GE Healthcare Innova 4100'° and Innova 3100 devices are substantially equivalent to the currently marketed devices Innova… | 2005 |
| * | K033244 | Digital Fluoroscopic Imaging System, Model Innova 4100 with Tilt Table OptionSummary page 1…-1Q) (K050489). The GE Healthcare Innova 4100'° and Innova 3100 devices are substantially equivalent to the currently marketed devices Innova 4100 device cleared under K033244 and Innova 3100 device cleared under K031637. This opinion is based on the information contained in the comparison table and the… | 2003 |
| * | K031637 | Innova 3100Summary page 1…0'° and Innova 3100 devices are substantially equivalent to the currently marketed devices Innova 4100 device cleared under K033244 and Innova 3100 device cleared under K031637. This opinion is based on the information contained in the comparison table and the product data sheets. The Innova 3D is offer… | 2003 |
| † | K954355 | Advantage Windows 3D with Navigator Option | 1995 |
| † | K993037 | LCV+ Version 2 | 2000 |
| † | K022322 | Innova and Innova 2000 S | 2002 |
What descends from it? (74)
See all 748 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060259 | Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121 | 2006 | 47 |
| K061163 | Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ… | 2006 | 22 |
| K101868 | Infinix-I Interventional Angiography System Model Infx-8000V | 2010 | 21 |
| K081624 | Infx-8000F (Infinix Csi and Infinix Dpi) | 2008 | 13 |
| K091658 | GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models Innova 4100, 3100… | 2009 | 11 |
| K081621 | Infx-8000C (Infinix CC-I and VC-I) | 2008 | 10 |
| K152352 | Stereo 3D option for Vision Applications | 2016 | 1 |
| K092004 | GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQ | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 4, 2014 | Class II | Z-0453-2015 | Device Design | Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism. |
| Dec 20, 2011 | Class II | Z-1318-2013 | Nonconforming Material/Component | While performing a fluoroscopic examination on the GE Innova systems, there is a potential of nonrecoverable loss of imaging modes with no advance warning, due to a relay failure in the power distribution box (PDB). Although no injuries… |
| Oct 21, 2011 | Class II | Z-1142-2013 | Labeling design | As part of GE Innova IQ table introduction, a label was designed to be affixed on the front Cover of the Gantry Pivot section. This safety label is missing on systems manufactured between March 2010 and July 2011. In the situation a staff… |
| Aug 24, 2011 | Not classified | Z-0133-2012 | Nonconforming Material/Component | A potential weakness on the monitor suspension end-stop device may impact user safety. The end-stops may break if the monitor-suspension is repeatedly pushed with excessive force on the end rails. |
| May 16, 2011 | Class II | Z-1616-2013 | Software design | GE Healthcare reported a potential safety issue due to temporary loss of X-Ray Imaging Modes during Collimator Auto-Calibration which affects Innova 3100 and Innova 4100 Systems. |
| Feb 4, 2011 | Class II | Z-0934-2013 | Nonconforming Material/Component | Exposed high voltage wires inside the cabinet . On a cable located in the system cabinet, two of the shrink tubings covering the 400V live cable leave an area potentially unprotected. |
| Mar 24, 2010 | Not classified | Z-1660-2010 | Software design | A potential software failure related to the Worklist functionality has been identified on a subset of Innova 2100IQ, 3100IQ and 4100IQ systems. When using the Worklist function to import patient data to Innova, there are two scenarios… |
| Mar 24, 2010 | Not classified | Z-1659-2010 | Software design | A potential software failure related to the Worklist functionality has been identified on a subset of Innova 2100IQ, 3100IQ and 4100IQ systems. When using the Worklist function to import patient data to Innova, there are two scenarios… |
| Mar 24, 2010 | Not classified | Z-1661-2010 | Software design | A potential software failure related to the Worklist functionality has been identified on a subset of Innova 2100IQ, 3100IQ and 4100IQ systems. When using the Worklist function to import patient data to Innova, there are two scenarios… |
| Dec 22, 2009 | Not classified | Z-0618-2010 | Device Design | Potential table rotation of Omega IV and Omega V tables affecting Advantx-E and Innova 2000, 2100IQ, 3100, 3100IQ, 4100, 4100IQ, 2121IQ and 3131IQ cardiovascular X-ray imaging systems. Due to potential weakness of some table rotational… |
| Dec 22, 2009 | Not classified | Z-0617-2010 | Device Design | Potential table rotation of Omega IV and Omega V tables affecting Advantx-E and Innova 2000, 2100IQ, 3100, 3100IQ, 4100, 4100IQ, 2121IQ and 3131IQ cardiovascular X-ray imaging systems. Due to potential weakness of some table rotational… |
| Dec 22, 2009 | Not classified | Z-0619-2010 | Device Design | Potential table rotation of Omega IV and Omega V tables affecting Advantx-E and Innova 2000, 2100IQ, 3100, 3100IQ, 4100, 4100IQ, 2121IQ and 3131IQ cardiovascular X-ray imaging systems. Due to potential weakness of some table rotational… |
| Aug 5, 2009 | Not classified | Z-0408-2011 | Nonconforming Material/Component | GE Healthcare has become aware of a potential issue regarding Innova systems with GE Fluoro UPS 20KVA that may impact patient safety. GE Fluoro UPS 20KVA (Uninterrupted Power Supply) is used to maintain fluoroscopy availability for… |
| Aug 5, 2009 | Not classified | Z-0410-2011 | Nonconforming Material/Component | GE Healthcare has become aware of a potential issue regarding Innova systems with GE Fluoro UPS 20KVA that may impact patient safety. GE Fluoro UPS 20KVA (Uninterrupted Power Supply) is used to maintain fluoroscopy availability for… |
| Aug 5, 2009 | Not classified | Z-0409-2011 | Nonconforming Material/Component | GE Healthcare has become aware of a potential issue regarding Innova systems with GE Fluoro UPS 20KVA that may impact patient safety. GE Fluoro UPS 20KVA (Uninterrupted Power Supply) is used to maintain fluoroscopy availability for… |
| Apr 16, 2009 | Not classified | Z-0136-2010 | Device Design | Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be informed with a message on the n-room… |
| Apr 16, 2009 | Not classified | Z-0135-2010 | Device Design | Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be informed with a message on the n-room… |
| Apr 16, 2009 | Not classified | Z-0137-2010 | Device Design | Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be informed with a message on the n-room… |
| Nov 4, 2008 | Not classified | Z-1036-2009 | Radiation Control for Health and Safety Act | One of three copper spectral filters could remain within the x-ray while the system displays no spectral filter. The displayed Air Kerma rate and thus cumulative Air Kerma are overestimated. The Air Kerma rate may be over estimated by up… |
| Oct 9, 2008 | Not classified | Z-1691-2009 | Radiation Control for Health and Safety Act | GE Healthcare has become aware of an Air Kerma Rate issue associated with a large Equivalent Patient Thickness (EPT) on the Innova system that my impact patient safety. During a Maximum Air Kerma Rate (AKR) calibration procedure check, GE… |
| Oct 9, 2008 | Not classified | Z-1688-2009 | Radiation Control for Health and Safety Act | GE Healthcare has become aware of an Air Kerma Rate issue associated with a large Equivalent Patient Thickness (EPT) on the Innova system that my impact patient safety. During a Maximum Air Kerma Rate (AKR) calibration procedure check, GE… |
| Oct 9, 2008 | Not classified | Z-1687-2009 | Radiation Control for Health and Safety Act | GE Healthcare has become aware of an Air Kerma Rate issue associated with a large Equivalent Patient Thickness (EPT) on the Innova system that my impact patient safety. During a Maximum Air Kerma Rate (AKR) calibration procedure check, GE… |
| Oct 9, 2008 | Not classified | Z-1690-2009 | Radiation Control for Health and Safety Act | GE Healthcare has become aware of an Air Kerma Rate issue associated with a large Equivalent Patient Thickness (EPT) on the Innova system that my impact patient safety. During a Maximum Air Kerma Rate (AKR) calibration procedure check, GE… |
| Oct 9, 2008 | Not classified | Z-1689-2009 | Radiation Control for Health and Safety Act | GE Healthcare has become aware of an Air Kerma Rate issue associated with a large Equivalent Patient Thickness (EPT) on the Innova system that my impact patient safety. During a Maximum Air Kerma Rate (AKR) calibration procedure check, GE… |
| Jul 25, 2008 | Not classified | Z-2438-2008 | Device Design | The charger and / or battery of the PDB may fail earlier than expected with no advance warning and thus cause the system to shut down. |
| Jul 25, 2008 | Not classified | Z-2436-2008 | Device Design | The charger and / or battery of the PDB may fail earlier than expected with no advance warning and thus cause the system to shut down. |
| Jul 25, 2008 | Not classified | Z-2437-2008 | Device Design | The charger and / or battery of the PDB may fail earlier than expected with no advance warning and thus cause the system to shut down. |
| Jun 24, 2008 | Not classified | Z-2357-2008 | Employee error | GE Healthcare has become aware of 2 potential conditions that could occur with the MAVIG GD Monitor Suspension that is used with Advantx-E, Innova 2000, 21000IQ, 3100/3100IQ, 4100/4100IQ and 2121 IQ/3131IQ cardiovascular systems. The two… |
| Jun 24, 2008 | Not classified | Z-2356-2008 | Employee error | GE Healthcare has become aware of 2 potential conditions that could occur with the MAVIG GD Monitor Suspension that is used with Advantx-E, Innova 2000, 21000IQ, 3100/3100IQ, 4100/4100IQ and 2121 IQ/3131IQ cardiovascular systems. The two… |
| Jun 24, 2008 | Not classified | Z-2358-2008 | Employee error | GE Healthcare has become aware of 2 potential conditions that could occur with the MAVIG GD Monitor Suspension that is used with Advantx-E, Innova 2000, 21000IQ, 3100/3100IQ, 4100/4100IQ and 2121 IQ/3131IQ cardiovascular systems. The two… |
| Jun 17, 2008 | Not classified | Z-1475-2009 | Process control | GE Healthcare has become aware that a few customers have experienced an unusual occurrence of system lockups on Innova single plane cardiovascular X-ray imaging systems while using the image auto-archiving function. when occurring during… |
| Jun 17, 2008 | Not classified | Z-1476-2009 | Process control | GE Healthcare has become aware that a few customers have experienced an unusual occurrence of system lockups on Innova single plane cardiovascular X-ray imaging systems while using the image auto-archiving function. when occurring during… |
| Jun 17, 2008 | Not classified | Z-1474-2009 | Process control | GE Healthcare has become aware that a few customers have experienced an unusual occurrence of system lockups on Innova single plane cardiovascular X-ray imaging systems while using the image auto-archiving function. when occurring during… |
| Jan 30, 2008 | Not classified | Z-0473-2009 | Software design | Software error, computer: GE Healthcare has became aware of an issue with Error Management affecting the Innova 2100, 3100/3100 IQ & 4100/4100IQ. It was reported that when the foot switch was pressed, the live monitor screen was blank and… |
| Jan 30, 2008 | Not classified | Z-0475-2009 | Software design | Software error, computer: GE Healthcare has became aware of an issue with Error Management affecting the Innova 2100, 3100/3100 IQ & 4100/4100IQ. It was reported that when the foot switch was pressed, the live monitor screen was blank and… |
| Jan 30, 2008 | Not classified | Z-0474-2009 | Software design | Software error, computer: GE Healthcare has became aware of an issue with Error Management affecting the Innova 2100, 3100/3100 IQ & 4100/4100IQ. It was reported that when the foot switch was pressed, the live monitor screen was blank and… |
| Jan 14, 2008 | Not classified | Z-2039-2008 | Process control | Risk of sudden table drop on Omega IV and Omega V tables on GE Healthcare Advantx-E as well as on Innova 2000, 2100IQ, 3100/3100 IQ and 4100/4100IQ cardiovascular X-ray system |
| Jan 14, 2008 | Not classified | Z-2040-2008 | Process control | Risk of sudden table drop on Omega IV and Omega V tables on GE Healthcare Advantx-E as well as on Innova 2000, 2100IQ, 3100/3100 IQ and 4100/4100IQ cardiovascular X-ray system |
| Jan 14, 2008 | Not classified | Z-2041-2008 | Process control | Risk of sudden table drop on Omega IV and Omega V tables on GE Healthcare Advantx-E as well as on Innova 2000, 2100IQ, 3100/3100 IQ and 4100/4100IQ cardiovascular X-ray system |
| Nov 15, 2007 | Not classified | Z-0692-2008 | Device Design | Frozen Image Problems: During an acquisition (fluoro and/or record), there have been cases reported where an image became "frozen" on the DL (digital leader acquisition system) live monitor screen. In such cases, the system continued to… |
| Nov 15, 2007 | Not classified | Z-0691-2008 | Device Design | Frozen Image Problems: During an acquisition (fluoro and/or record), there have been cases reported where an image became "frozen" on the DL (digital leader acquisition system) live monitor screen. In such cases, the system continued to… |
| Mar 26, 2007 | Not classified | Z-0871-2007 | Other | Measurement errors during the computation of vessel diameters while using the Stenosis Analysis software (also known as Quantitative Coronary Analysis function-QCA) using the auto-calibration function on Innova Digital (located in control… |
| Mar 26, 2007 | Not classified | Z-0870-2007 | Other | Measurement errors during the computation of vessel diameters while using the Stenosis Analysis software (also known as Quantitative Coronary Analysis function-QCA) using the auto-calibration function on Innova Digital (located in control… |
| Mar 26, 2007 | Not classified | Z-0869-2007 | Other | Measurement errors during the computation of vessel diameters while using the Stenosis Analysis software (also known as Quantitative Coronary Analysis function-QCA) using the auto-calibration function on Innova Digital (located in control… |
| Mar 26, 2007 | Not classified | Z-1044-2007 | Other | Caution on the non-detection of small invasive objects/devices, which project out from the skin surfaces (e.g. biopsy or other needles) while using the Innova Sense software option designed for patient contouring. Usage of Innova Sense… |
| Mar 26, 2007 | Not classified | Z-1043-2007 | Other | Caution on the non-detection of small invasive objects/devices, which project out from the skin surfaces (e.g. biopsy or other needles) while using the Innova Sense software option designed for patient contouring. Usage of Innova Sense… |
| Feb 5, 2007 | Not classified | Z-0913-2007 | Other | Unintended Gantry Movements : GE Healthcare has recently become aware of accidental, operated-initiated activation of gantry movements associated with the new, metallic Smart Box controller, that may impact patient or staff safely. |
| Aug 17, 2006 | Not classified | Z-1518-2008 | Radiation Control for Health and Safety Act | User was unable to hear the Innova 2100-IQ 5-minute fluoroscopy warning signal from the Table Control TSSC interface. Inability of the user to hear the audible signal indicating the completion of any preset exposure time may lead to… |
| Aug 17, 2006 | Not classified | Z-1519-2008 | Radiation Control for Health and Safety Act | User was unable to hear the Innova 2100-IQ 5-minute fluoroscopy warning signal from the Table Control TSSC interface. Inability of the user to hear the audible signal indicating the completion of any preset exposure time may lead to… |
| Aug 17, 2006 | Not classified | Z-1520-2008 | Radiation Control for Health and Safety Act | User was unable to hear the Innova 2100-IQ 5-minute fluoroscopy warning signal from the Table Control TSSC interface. Inability of the user to hear the audible signal indicating the completion of any preset exposure time may lead to… |
The 5 latest of 50 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 10 of the 14 ancestors have a recall of any class.
- Of its descendants, K060259 (Ge Medical Systems, LLC, 2006) has gone furthest, with 47 descendants of its own.
- 1 other device also cites its predicate K974715.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OWB
22in 2025
2007high 24 (2021) · low 3 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
2007high 221 (2026) · low 37 (2012)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
2007high 42 (2026) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
2007high 14,008 (2025) · low 0 (2008)2025
MAUDE reports naming product code OWB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscoplc images obtained through image intensifier technology. Those devices are…
Read the full statement (115 words)
The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures.
They are intended to replace fluoroscoplc images obtained through image intensifier technology. Those devices are not intended for mammography applications.
Innova 3D is a software option which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up. It is not intended for mammography applications.
InnovaSpin is a software option that permits fast spin rotational angiography. 1t is not intended for mammography applications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K052412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052412: Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052412
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026