510(k) · Cleared
Recalled · Class II · 2012GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models Innova 4100, 3100, 2100, 3131, 2121
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 Jun 29, 2009 as substantially equivalent to K052412 (GE Healthcare, 2005) and 3 other predicates after a 20-day review. Its family tree reaches back 8 generations to 1989. 11 later devices descend from it. It has been recalled once.
- Decided
- Jun 29, 2009
- Review
- 20 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 8 generations to K890348 (1989). 18 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 7 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 6 generations backK022322 Innova and Innova 2000 SGe Medical Systems, Inc. · 2002 · Recalled
- 5 generations backK031637 Innova 3100GE Medical Systems · 2003 · Recalled
- 4 generations backK050489 Innova 2100Ge Medical Systems, LLC · 2005 · Recalled
- 3 generations backK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- 2 generations backK060259 Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC · 2006 · Recalled
- 1 generation backK061163 Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova…Ge Medical Systems, LLC · 2006 · Recalled
- This deviceK091658 GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models…GE Healthcare · 2009
- Descendant · cites it directly · 10 of its ownK092439 Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc. · 2009
- Descendant · cites it directly · 5 of its ownK093688 Canon, Model Urs-50RFVirtual Imaging, Inc. · 2010
- Descendant · 2 generations on · 3 of its ownK171194 AS-10, Cxdi-401RFCanon, Inc. · 2017
- Descendant · 2 generations on · 3 of its ownK102529 D2RF Digital Dynamic Remote SystemStephanix Radiological Systems · 2010 · Recalled
- Descendant · 3 generations on · 1 of its ownK232298 DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc. · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc. · 2009 · cites it directly10descendants
- K093688Canon, Model Urs-50RFVirtual Imaging, Inc. · 2010 · cites it directly5descendants
- K171194AS-10, Cxdi-401RFCanon, Inc. · 2017 · 2 generations on3descendants
- K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems · 2010 · 2 generations on3descendants
- K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc. · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −7 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −6 | K022322 | Innova and Innova 2000 S | Ge Medical Systems, Inc. | 2002 | 7 |
| −5 | K031637 | Innova 3100 | GE Medical Systems | 2003 | 25 |
| −4 | K050489 | Innova 2100 | Ge Medical Systems, LLC | 2005 | 27 |
| −3 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| −2 | K060259 | Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121 | Ge Medical Systems, LLC | 2006 | 4 |
| −1 | K061163 | Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova… | Ge Medical Systems, LLC | 2006 | 38 |
| 0 (this device) | K091658 | GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models Innova… | GE Healthcare | 2009 | — |
| +1 | K092439 | Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RF | Virtual Imaging, Inc. | 2009 | — |
| +1 | K093688 | Canon, Model Urs-50RF | Virtual Imaging, Inc. | 2010 | — |
| +2 | K171194 | AS-10, Cxdi-401RF | Canon, Inc. | 2017 | — |
| +2 | K102529 | D2RF Digital Dynamic Remote System | Stephanix Radiological Systems | 2010 | 1 |
| +3 | K232298 | DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl | Canon, Inc. | 2024 | — |
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 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 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 18.3 · 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 |
|---|---|---|---|
| * | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQSummary page 1…Innova in Operating-Room environment Innova 4100', 3100'%, 2100'°, 31312, 2121 @ Svstem X-Ray, Angiographic e OWR, HAK, [2] Innova 41009, 3100'°, 2100'°, 31311, 2121% K052412, K050489, K060259, K061163. The Innova series digital fluoroscopy systems labeling is modified to allow the use of this device i… | 2005 |
| * | K050489 | Innova 2100Summary page 1…n Operating-Room environment Innova 4100', 3100'%, 2100'°, 31312, 2121 @ Svstem X-Ray, Angiographic e OWR, HAK, [2] Innova 41009, 3100'°, 2100'°, 31311, 2121% K052412, K050489, K060259, K061163. The Innova series digital fluoroscopy systems labeling is modified to allow the use of this device in an Oper… | 2005 |
| * | K060259 | Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Summary page 1…ng-Room environment Innova 4100', 3100'%, 2100'°, 31312, 2121 @ Svstem X-Ray, Angiographic e OWR, HAK, [2] Innova 41009, 3100'°, 2100'°, 31311, 2121% K052412, K050489, K060259, K061163. The Innova series digital fluoroscopy systems labeling is modified to allow the use of this device in an Operating Roo… | 2006 |
| * | K061163 | Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ…Summary page 1…nvironment Innova 4100', 3100'%, 2100'°, 31312, 2121 @ Svstem X-Ray, Angiographic e OWR, HAK, [2] Innova 41009, 3100'°, 2100'°, 31311, 2121% K052412, K050489, K060259, K061163. The Innova series digital fluoroscopy systems labeling is modified to allow the use of this device in an Operating Room environ… | 2006 |
What descends from it? (11)
See all 112 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 14 of the 18 ancestors have a recall of any class.
- Of its descendants, K092439 (Virtual Imaging, Inc., 2009) has gone furthest, with 10 descendants of its own.
- 7 other devices also cite its predicate K052412.
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. 2009, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 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. These devices are 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/K091658 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091658: GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models Innova 4100, 3100, 2100, 3131, 2121.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091658
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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