510(k) · Cleared
Recalled · Class II · 2019GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with Cathlab Frontiers Solutions
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 Jan 2, 2013 as substantially equivalent to K113034 (GE Healthcare, 2011) and 2 other predicates after a 142-day review. Its family tree reaches back 10 generations to 1989. 5 later devices descend from it. It has been recalled 20 times.
- Decided
- Jan 2, 2013
- Review
- 142 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 20
- Predicates
- 3
Its longest line of descent runs back 10 generations to K890348 (1989). 57 ancestors in all, the oldest K801623 (1980). 5 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 6 generations between
- 3 generations backK061163 Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova…Ge Medical Systems, LLC · 2006 · Recalled
- 2 generations backK111209 Integrated Innova - S5I System OptionGE Healthcare · 2011 · Recalled
- 1 generation backK113034 GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare · 2011
- This deviceK122457 GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic…GE Healthcare · 2013
- Descendant · cites it directly · 4 of its ownK133278 Discovery Igs 740GE Medical Systems SCS · 2014 · Recalled
- Descendant · cites it directly · 3 of its ownK181403 Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 ORGE Healthcare · 2018 · Recalled
- Descendant · 2 generations on · 1 of its ownK232344 Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 ORGE Medical Systems SCS · 2023 · Recalled
- Descendant · 3 generations on · 0 of its ownK251199 Allia MoveoGE Medical Systems SCS · 2025 · Recalled
- Descendant · 2 generations on · 0 of its ownK243446 3DXRGE Medical Systems SCS · 2025
Show all 10 generations
- Root · 10 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 9 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 8 generations backK022322 Innova and Innova 2000 SGe Medical Systems, Inc. · 2002 · Recalled
- 7 generations backK031637 Innova 3100GE Medical Systems · 2003 · Recalled
- 6 generations backK050489 Innova 2100Ge Medical Systems, LLC · 2005 · Recalled
- 5 generations backK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- 4 generations backK060259 Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC · 2006 · Recalled
- 3 generations backK061163 Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova…Ge Medical Systems, LLC · 2006 · Recalled
- 2 generations backK111209 Integrated Innova - S5I System OptionGE Healthcare · 2011 · Recalled
- 1 generation backK113034 GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare · 2011
- This deviceK122457 GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic…GE Healthcare · 2013
Most influential descendants
Showing 5 of 5 · See all- K133278Discovery Igs 740GE Medical Systems SCS · 2014 · cites it directly4descendants
- K181403Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 ORGE Healthcare · 2018 · cites it directly3descendants
- K232344Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 ORGE Medical Systems SCS · 2023 · 2 generations on1descendant
- K251199Allia MoveoGE Medical Systems SCS · 2025 · 3 generations on0descendants
- K2434463DXRGE Medical Systems SCS · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −9 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −8 | K022322 | Innova and Innova 2000 S | Ge Medical Systems, Inc. | 2002 | 7 |
| −7 | K031637 | Innova 3100 | GE Medical Systems | 2003 | 25 |
| −6 | K050489 | Innova 2100 | Ge Medical Systems, LLC | 2005 | 27 |
| −5 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| −4 | K060259 | Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121 | Ge Medical Systems, LLC | 2006 | 4 |
| −3 | K061163 | Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova… | Ge Medical Systems, LLC | 2006 | 38 |
| −2 | K111209 | Integrated Innova - S5I System Option | GE Healthcare | 2011 | 2 |
| −1 | K113034 | GE Innova Solid State Xray Imager Flurosopic X Ray System | GE Healthcare | 2011 | — |
| 0 (this device) | K122457 | GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray… | GE Healthcare | 2013 | — |
| +1 | K133278 | Discovery Igs 740 | GE Medical Systems SCS | 2014 | 5 |
| +1 | K181403 | Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR | GE Healthcare | 2018 | 6 |
| +2 | K232344 | Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR | GE Medical Systems SCS | 2023 | 7 |
| +3 | K251199 | Allia Moveo | GE Medical Systems SCS | 2025 | 1 |
| +2 | K243446 | 3DXR | GE Medical Systems SCS | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 12 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K113034 | GE Innova Solid State Xray Imager Flurosopic X Ray SystemSummary page 6…GE Healthcare 510(k) Premarket Notification Submission Predicate Device(s): K113034 : GE Innova Solid State X-ray Imager Fluoroscopic X- ray System K111209 :… | 2011 |
| * | K111209 | Integrated Innova - S5I System OptionSummary page 6…Submission Predicate Device(s): K113034 : GE Innova Solid State X-ray Imager Fluoroscopic X- ray System K111209 : Integrated Innova - S5i System Option K113403 : GE Discovery IGS angiographic, fluoroscopic X-Ray… | 2011 |
| * | K113403 | GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemSummary page 6…ay Imager Fluoroscopic X- ray System K111209 : Integrated Innova - S5i System Option K113403 : GE Discovery IGS angiographic, fluoroscopic X-Ray System Device Description:… | 2012 |
What descends from it? (5)
2 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 |
|---|---|---|---|---|
| Mar 15, 2019 | Class II | Z-1200-2019 | Device Design | There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously. |
| Mar 29, 2018 | Class II | Z-2387-2018 | Process control | The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use. |
| Mar 29, 2018 | Class II | Z-2386-2018 | Process control | The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use. |
| Dec 18, 2015 | Class II | Z-0763-2016 | Nonconforming Material/Component | GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor. |
| Nov 13, 2015 | Class II | Z-0414-2016 | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems. |
| Nov 13, 2015 | Class II | Z-0413-2016 | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems . |
| May 29, 2015 | Class II | Z-1984-2015 | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). |
| May 29, 2015 | Class II | Z-1981-2015 | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). |
| May 29, 2015 | Class II | Z-1977-2015 | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). |
| May 29, 2015 | Class II | Z-1983-2015 | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). |
| May 29, 2015 | Class II | Z-1985-2015 | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). |
| May 29, 2015 | Class II | Z-1974-2015 | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). |
| May 29, 2015 | Class II | Z-1980-2015 | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). |
| May 29, 2015 | Class II | Z-1978-2015 | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). |
| May 29, 2015 | Class II | Z-1982-2015 | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). |
| May 29, 2015 | Class II | Z-1976-2015 | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). |
| May 29, 2015 | Class II | Z-1973-2015 | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). |
| May 29, 2015 | Class II | Z-1979-2015 | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). |
| Sep 4, 2014 | Class II | Z-0451-2015 | 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. |
| Nov 15, 2013 | Class II | Z-0853-2014 | Software design | GE Healthcare has recently become aware of a potential safety issue with respect to IGS 630 Imaging Systems. While performing fluoroscopy on a biplane fluoroscopy unit, there is a potential for loss of the x-ray imaging function when the… |
The 5 latest of 20 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 24 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 20 of the 57 ancestors have a recall of any class.
- Of its descendants, K133278 (GE Medical Systems SCS, 2014) has gone furthest, with 4 descendants of its own.
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. 2013, 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 angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is…
Read the full statement (201 words)
The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures.
The OR table is suitable for interventional and surgical procedures. .
The Cathlab Frontiers solutions are indicated for use in conjunction with single plane and biplane GE angiographic X-ray systems and imaging / data medical devices used in interventional and surgical cathlab environments and cleared for commercial distribution.
The Cathlab Frontiers solutions are integrated GE angiographic X-ray and imaging / data medical devices that simplify the end-to-end clinical workflow in the cathlab by implementing: -
(1) communication protocols for exchanging and automatically synchronizing patient, exam, system, and image information between the angiographic X-ray systems and the imaging / data medical devices,
(2) communication protocols for the control of imaging / data medical device functions from the angiographic X-ray systems user interface,
(3) interfaces for displaying the imaging / data medical device output on the monitor display solutions of the GE angiographic X-ray systems.
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/K122457 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122457: GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with Cathlab Frontiers Solutions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122457
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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