510(k) · Cleared
Recalled · Class II · 2013Innova CT Option for Digital Fluoroscopic Imaging Systems Innova Models 4100, 4100IQ, 3100, 3100IQ & 2100IQ
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · JAK System, X-Ray, Tomography, Computed
Cleared on Aug 25, 2005 as substantially equivalent to K042646 (Siemens Medical Systems, Inc., 2004) after a 17-day review. Its family tree reaches back 1 generation to 2004. It has been recalled 39 times.
- Decided
- Aug 25, 2005
- Review
- 17 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 39
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042646 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK042646 DynactSiemens Medical Systems, Inc. · 2004
- This deviceK052157 Innova CT Option for Digital Fluoroscopic Imaging Systems Innova…Ge Medical Systems, LLC · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042646 | Dynact | Siemens Medical Systems, Inc. | 2004 | — |
| 0 (this device) | K052157 | Innova CT Option for Digital Fluoroscopic Imaging Systems Innova Models 4100… | Ge Medical Systems, LLC | 2005 | — |
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 JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K042646 | DynactSummary page 1…n is substantially equivalent to the currently marketed DynaCT option of Slermens Vascular Angiographic system (K042646). The Innova CT is intended for use with Innova44100 (renamed Innova. 4 10 0'0 and previously… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 21, 2013 | Class II | Z-0947-2013 | Nonconforming Material/Component | A locking nut might loosen out of the overhead Video Monitor Suspension yoke affecting Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, and Innova 4100IQ Cardiovascular X-ray imaging systems. |
| 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. |
| 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-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-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-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… |
| 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 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-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 |
| 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… |
| 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… |
| 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… |
| 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… |
| 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… |
The 5 latest of 39 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K042646.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
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. This device is not…
Read the full statement (118 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. This device is not intended for mammography applications.
Innova CT is a software option which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to provide images that assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up.
Innova CT is intended for imaging bone and soft tissues as well as other internal body structures.
Innova CT is not intended for mammography applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052157: Innova CT Option for Digital Fluoroscopic Imaging Systems Innova Models 4100, 4100IQ, 3100, 3100IQ & 2100IQ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052157
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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