510(k) · Cleared
Recalled · Class II · 2024Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR
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 Nov 2, 2018 as substantially equivalent to K122457 (GE Healthcare, 2013) and 1 other predicate after a 157-day review. Its family tree reaches back 12 generations to 1989. 3 later devices descend from it. It has been recalled 6 times.
- Decided
- Nov 2, 2018
- Review
- 157 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 12 generations to K890348 (1989). 59 ancestors in all, the oldest K801623 (1980). 3 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 8 generations between
- 3 generations backK113034 GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare · 2011
- 2 generations backK122457 GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic…GE Healthcare · 2013 · Recalled
- 1 generation backK133278 Discovery Igs 740GE Medical Systems SCS · 2014 · Recalled
- This deviceK181403 Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 ORGE Healthcare · 2018
- Descendant · cites it directly · 1 of its ownK232344 Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 ORGE Medical Systems SCS · 2023 · Recalled
- Descendant · 2 generations on · 0 of its ownK251199 Allia MoveoGE Medical Systems SCS · 2025 · Recalled
- Descendant · cites it directly · 0 of its ownK243446 3DXRGE Medical Systems SCS · 2025
Show all 12 generations
- Root · 12 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 11 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 10 generations backK022322 Innova and Innova 2000 SGe Medical Systems, Inc. · 2002 · Recalled
- 9 generations backK031637 Innova 3100GE Medical Systems · 2003 · Recalled
- 8 generations backK050489 Innova 2100Ge Medical Systems, LLC · 2005 · Recalled
- 7 generations backK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- 6 generations backK060259 Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC · 2006 · Recalled
- 5 generations backK061163 Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova…Ge Medical Systems, LLC · 2006 · Recalled
- 4 generations backK111209 Integrated Innova - S5I System OptionGE Healthcare · 2011 · Recalled
- 3 generations backK113034 GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare · 2011
- 2 generations backK122457 GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic…GE Healthcare · 2013 · Recalled
- 1 generation backK133278 Discovery Igs 740GE Medical Systems SCS · 2014 · Recalled
- This deviceK181403 Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 ORGE Healthcare · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −11 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −10 | K022322 | Innova and Innova 2000 S | Ge Medical Systems, Inc. | 2002 | 7 |
| −9 | K031637 | Innova 3100 | GE Medical Systems | 2003 | 25 |
| −8 | K050489 | Innova 2100 | Ge Medical Systems, LLC | 2005 | 27 |
| −7 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| −6 | K060259 | Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121 | Ge Medical Systems, LLC | 2006 | 4 |
| −5 | K061163 | Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova… | Ge Medical Systems, LLC | 2006 | 38 |
| −4 | K111209 | Integrated Innova - S5I System Option | GE Healthcare | 2011 | 2 |
| −3 | K113034 | GE Innova Solid State Xray Imager Flurosopic X Ray System | GE Healthcare | 2011 | — |
| −2 | K122457 | GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray… | GE Healthcare | 2013 | 20 |
| −1 | K133278 | Discovery Igs 740 | GE Medical Systems SCS | 2014 | 5 |
| 0 (this device) | K181403 | Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR | GE Healthcare | 2018 | — |
| +1 | K232344 | Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR | GE Medical Systems SCS | 2023 | 7 |
| +2 | K251199 | Allia Moveo | GE Medical Systems SCS | 2025 | 1 |
| +1 | 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 |
|---|---|---|
| 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 18.2 · 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? (2)
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 |
|---|---|---|---|
| * | K122457 | GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with…Summary page 5…X-ray systems with Cathlab Frontiers solutions. 510(k) Clearance: K122457 Regulation Name: Image-Intensified fluoroscopic x-ray… | 2013 |
| * | K133278 | Discovery Igs 740Summary page 5…Secondary Product codes: IZI, JAA Trade Name: Discovery IGSTM 740 510(k) Clearance: K133278 Regulation Name: Image-Intensified fluoroscopic x-ray… | 2014 |
What descends from it? (3)
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 18, 2024 | Class II | Z-1777-2024 | Process control | GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential… |
| Mar 18, 2024 | Class II | Z-1783-2024 | Process control | GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential… |
| Mar 18, 2024 | Class II | Z-1782-2024 | Process control | GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential… |
| Mar 18, 2024 | Class II | Z-1778-2024 | Process control | GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential… |
| Apr 19, 2021 | Class II | Z-1864-2021 | Component change control | The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two unequal image parts within the monitor display screen. |
| Mar 15, 2019 | Class II | Z-1201-2019 | 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. |
The 5 latest of 6 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 29 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 22 of the 59 ancestors have a recall of any class.
- Of its descendants, K232344 (GE Medical Systems SCS, 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K122457.
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. 2018, 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 suitable for interventional and surgical procedures.
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/K181403 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181403: Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181403
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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