510(k) · Cleared
Recalled · Class II · 2012Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ, Innova 2100IQ with Innova Ivus Opt
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · OWB Interventional Fluoroscopic X-Ray System
Cleared on Jun 7, 2006 as substantially equivalent to K060259 (Ge Medical Systems, LLC, 2006) and 4 other predicates after a 42-day review. Its family tree reaches back 7 generations to 1989. 22 later devices descend from it. It has been recalled 38 times.
- Decided
- Jun 7, 2006
- Review
- 42 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 38
- Predicates
- 5
Its longest line of descent runs back 7 generations to K890348 (1989). 17 ancestors in all. 22 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 6 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 5 generations backK022322 Innova and Innova 2000 SGe Medical Systems, Inc. · 2002 · Recalled
- 4 generations backK031637 Innova 3100GE Medical Systems · 2003 · Recalled
- 3 generations backK050489 Innova 2100Ge Medical Systems, LLC · 2005 · Recalled
- 2 generations backK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- 1 generation backK060259 Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC · 2006 · Recalled
- This deviceK061163 Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova…Ge Medical Systems, LLC · 2006
- Descendant · cites it directly · 11 of its ownK091658 GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models…GE Healthcare · 2009 · Recalled
- Descendant · 2 generations on · 10 of its ownK092439 Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc. · 2009
- Descendant · cites it directly · 8 of its ownK111209 Integrated Innova - S5I System OptionGE Healthcare · 2011 · Recalled
- Descendant · 2 generations on · 6 of its ownK113403 GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemGE Medical Systems SCS · 2012 · Recalled
- Descendant · 2 generations on · 6 of its ownK113034 GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare · 2011
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
2009high 3 (2009) · low 0 (2016)2026
Most influential descendants
Showing 5 of 22 · See all- K091658GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models Innova 4100, 3100…GE Healthcare · 2009 · cites it directly11descendants
- K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc. · 2009 · 2 generations on10descendants
- K111209Integrated Innova - S5I System OptionGE Healthcare · 2011 · cites it directly8descendants
- K113403GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemGE Medical Systems SCS · 2012 · 2 generations on6descendants
- K113034GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare · 2011 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −6 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −5 | K022322 | Innova and Innova 2000 S | Ge Medical Systems, Inc. | 2002 | 7 |
| −4 | K031637 | Innova 3100 | GE Medical Systems | 2003 | 25 |
| −3 | K050489 | Innova 2100 | Ge Medical Systems, LLC | 2005 | 27 |
| −2 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| −1 | K060259 | Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121 | Ge Medical Systems, LLC | 2006 | 4 |
| 0 (this device) | K061163 | Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova… | Ge Medical Systems, LLC | 2006 | — |
| +1 | K091658 | GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models Innova… | GE Healthcare | 2009 | 1 |
| +2 | K092439 | Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RF | Virtual Imaging, Inc. | 2009 | — |
| +1 | K111209 | Integrated Innova - S5I System Option | GE Healthcare | 2011 | 2 |
| +2 | K113403 | GE Discovery Igs Angiographic,Fluoroscopic X-Ray System | GE Medical Systems SCS | 2012 | 4 |
| +2 | K113034 | GE Innova Solid State Xray Imager Flurosopic X Ray System | GE Healthcare | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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 18.2 · 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? (5)
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 |
|---|---|---|---|
| * | K060259 | Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Summary page 1…re substantlally eguuvalent to the currently marketed GE Healthcare Innova 2121'“, Innova 3131 , Innova 4100blnnova 4100 Innova 3100, Innova 31009, Innova 2100" devices (K060259 K033244, K052412, K031 637 K050489) This opinion is based on the information contained in the comparison table and the product d… | 2006 |
| * | K033244 | Digital Fluoroscopic Imaging System, Model Innova 4100 with Tilt Table OptionSummary page 1…antlally eguuvalent to the currently marketed GE Healthcare Innova 2121'“, Innova 3131 , Innova 4100blnnova 4100 Innova 3100, Innova 31009, Innova 2100" devices (K060259 K033244, K052412, K031 637 K050489) This opinion is based on the information contained in the comparison table and the product data shee… | 2003 |
| * | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQSummary page 1…eguuvalent to the currently marketed GE Healthcare Innova 2121'“, Innova 3131 , Innova 4100blnnova 4100 Innova 3100, Innova 31009, Innova 2100" devices (K060259 K033244, K052412, K031 637 K050489) This opinion is based on the information contained in the comparison table and the product data sheets. The… | 2005 |
| * | K031637 | Innova 3100Summary page 1…t to the currently marketed GE Healthcare Innova 2121'“, Innova 3131 , Innova 4100blnnova 4100 Innova 3100, Innova 31009, Innova 2100" devices (K060259 K033244, K052412, K031 637 K050489) This opinion is based on the information contained in the comparison table and the product data sheets. The Innova IVU… | 2003 |
| * | K050489 | Innova 2100Summary page 1…currently marketed GE Healthcare Innova 2121'“, Innova 3131 , Innova 4100blnnova 4100 Innova 3100, Innova 31009, Innova 2100" devices (K060259 K033244, K052412, K031 637 K050489) This opinion is based on the information contained in the comparison table and the product data sheets. The Innova IVUS is off… | 2005 |
What descends from it? (22)
See all 223 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 16, 2012 | Class II | Z-2376-2012 | Software design | GE Healthcare has recently become aware of a potential safety issue with respect to the Innova 2121IQ & Innova 3131IQ Systems. While performing a fluoroscopic acquisition with the Innova 2121IQ or Innova 3131IQ systems, there is a… |
| 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… |
| 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-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… |
| 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-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… |
| 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-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… |
| Dec 22, 2009 | Not classified | Z-0621-2010 | 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… |
| 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… |
| Aug 5, 2009 | Not classified | Z-0407-2011 | 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-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… |
| 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… |
| Apr 16, 2009 | Not classified | Z-0138-2010 | 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-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… |
| Nov 21, 2008 | Not classified | Z-1195-2009 | Device Design | GE Healthcare has become aware of a potential image storage failure on Innova 2121 IQ/ 3131 IQ cardiovascular imaging systems that may impact patient safety. This intermittent communication failure on the image storage chain may result in… |
| 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-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-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-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… |
| 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… |
| 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. |
| Jun 24, 2008 | Not classified | Z-2360-2008 | 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-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 |
| Jan 14, 2008 | Not classified | Z-2043-2008 | 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-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 |
The 5 latest of 38 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 17 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 13 of the 17 ancestors have a recall of any class.
- Of its descendants, K091658 (GE Healthcare, 2009) has gone furthest, with 11 descendants of its own.
- 3 other devices also cite its predicate K060259.
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 fluoroscopic images obtained through image intensifier technology. Those devices are…
Read the full statement (138 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 fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications.
Innova IVUS option:
The Innova IVUS software option simplifies the clinical workflow associated with the use of Volcano IVUS products by:
(1) automatically synchronizing the patient demographic information (patient name, date of birth, DICOM attributes etc.) from Innova system with an IVUS imaging system,
(2) providing a remote access to commonly used IVUS functions from the Innova table side user interface.
(3) displaying the IVUS images on the multi-monitor display of the Innova cathlab system.
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/K061163 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061163: Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ, Innova 2100IQ with Innova Ivus Opt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061163
Report an extraction error
Are you the manufacturer?
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