510(k) · Cleared
Recalled · Class II · 2018GE Discovery Igs Angiographic,Fluoroscopic X-Ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems SCS · OWB Interventional Fluoroscopic X-Ray System
Cleared on Feb 14, 2012 as substantially equivalent to K111209 (GE Healthcare, 2011) and 1 other predicate after an 89-day review. Its family tree reaches back 9 generations to 1989. 6 later devices descend from it. It has been recalled 4 times.
- Decided
- Feb 14, 2012
- Review
- 89 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 9 generations to K890348 (1989). 55 ancestors in all, the oldest K801623 (1980). 6 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 5 generations between
- 3 generations backK060259 Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC · 2006 · Recalled
- 2 generations backK061163 Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova…Ge Medical Systems, LLC · 2006 · Recalled
- 1 generation backK111209 Integrated Innova - S5I System OptionGE Healthcare · 2011 · Recalled
- This deviceK113403 GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemGE Medical Systems SCS · 2012
- Descendant · cites it directly · 5 of its ownK122457 GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic…GE Healthcare · 2013 · Recalled
- Descendant · cites it directly · 4 of its ownK133278 Discovery Igs 740GE Medical Systems SCS · 2014 · Recalled
- Descendant · 2 generations on · 3 of its ownK181403 Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 ORGE Healthcare · 2018 · Recalled
- Descendant · 3 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 · 4 generations on · 0 of its ownK251199 Allia MoveoGE Medical Systems SCS · 2025 · Recalled
Show all 9 generations
- Root · 9 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 8 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 7 generations backK022322 Innova and Innova 2000 SGe Medical Systems, Inc. · 2002 · Recalled
- 6 generations backK031637 Innova 3100GE Medical Systems · 2003 · Recalled
- 5 generations backK050489 Innova 2100Ge Medical Systems, LLC · 2005 · Recalled
- 4 generations backK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- 3 generations backK060259 Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC · 2006 · Recalled
- 2 generations backK061163 Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova…Ge Medical Systems, LLC · 2006 · Recalled
- 1 generation backK111209 Integrated Innova - S5I System OptionGE Healthcare · 2011 · Recalled
- This deviceK113403 GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemGE Medical Systems SCS · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K122457GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with…GE Healthcare · 2013 · cites it directly5descendants
- 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 · 2 generations on3descendants
- K232344Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 ORGE Medical Systems SCS · 2023 · 3 generations on1descendant
- K251199Allia MoveoGE Medical Systems SCS · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −8 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −7 | K022322 | Innova and Innova 2000 S | Ge Medical Systems, Inc. | 2002 | 7 |
| −6 | K031637 | Innova 3100 | GE Medical Systems | 2003 | 25 |
| −5 | K050489 | Innova 2100 | Ge Medical Systems, LLC | 2005 | 27 |
| −4 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| −3 | K060259 | Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121 | Ge Medical Systems, LLC | 2006 | 4 |
| −2 | K061163 | Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova… | Ge Medical Systems, LLC | 2006 | 38 |
| −1 | K111209 | Integrated Innova - S5I System Option | GE Healthcare | 2011 | 2 |
| 0 (this device) | K113403 | GE Discovery Igs Angiographic,Fluoroscopic X-Ray System | GE Medical Systems SCS | 2012 | — |
| +1 | 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 |
| +2 | K181403 | Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR | GE Healthcare | 2018 | 6 |
| +3 | K232344 | Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR | GE Medical Systems SCS | 2023 | 7 |
| +4 | K251199 | Allia Moveo | GE Medical Systems SCS | 2025 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K111209 | Integrated Innova - S5I System OptionSummary page 1…oroscopic X- ray system Regulation Description: Regulation number: Product Code: Closs: Angiographic X- ray system 892.1600. 0121, owB, Jaa [ Predicate Devicels): K111209: INTEGRATED INNOVA - S5| SYSTEM OPTION GE Medical Systems K090745 : Siemens Artis Zee Device Description: The proposed device,… | 2011 |
| * | K090745 | Artis Zee / Zeegos with SW VC14Summary page 1…: Product Code: Closs: Angiographic X- ray system 892.1600. 0121, owB, Jaa [ Predicate Devicels): K111209: INTEGRATED INNOVA - S5| SYSTEM OPTION GE Medical Systems K090745 : Siemens Artis Zee Device Description: The proposed device, Discovery IGS 730 is an X-ray angiographic system with o 30cm dete… | 2009 |
What descends from it? (6)
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 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. |
| Apr 15, 2016 | Class II | Z-1706-2016 | Device Design | Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional procedure. |
| Dec 10, 2014 | Class II | Z-0966-2015 | Software design | Potential unintentional system motion or rotation due to a positioning user interface issue with Discovery IGS 730 and 740 products. |
| Jun 19, 2013 | Class II | Z-2253-2013 | Software design | GE Healthcare has recently become aware of a potential safety issue with respect to Discovery IGS 730 Imaging Systems. A patient data management error may prevent the Discovery IGS 730 Imaging System from booting on start-up or re-booting… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 19 of the 55 ancestors have a recall of any class.
- Of its descendants, K122457 (GE Healthcare, 2013) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K111209.
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. 2012, 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 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/K113403 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113403: GE Discovery Igs Angiographic,Fluoroscopic X-Ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113403
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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