510(k) · Cleared
ClearedGE Innova Solid State Xray Imager Flurosopic X Ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · IZI System, X-Ray, Angiographic
Cleared on Dec 13, 2011 as substantially equivalent to K111209 (GE Healthcare, 2011) and 1 other predicate after a 63-day review. Its family tree reaches back 9 generations to 1989. 6 later devices descend from it.
- Decided
- Dec 13, 2011
- Review
- 63 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- 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, 1 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 deviceK113034 GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare · 2011
- Descendant · cites it directly · 5 of its ownK122457 GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic…GE Healthcare · 2013 · Recalled
- Descendant · 2 generations on · 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 deviceK113034 GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare · 2011
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 · 2 generations on4descendants
- 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) | K113034 | GE Innova Solid State Xray Imager Flurosopic X Ray System | GE Healthcare | 2011 | — |
| +1 | K122457 | GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray… | GE Healthcare | 2013 | 20 |
| +2 | 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 IZI? 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 IZI device
- #1 K230727 SPY Portable Handheld Imaging (SPY-PHI) Systemscore 23.2 · 20 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…a 4100-IQ, 3100-IQ, 2100-Q) Classification Names: Angiographic x-ray system Product Code: IZI, 892.1600. Predicate Device(s): K<111209: INTEGRATED INNOVA -5S51 SYSTEM OPTION, K<090745 :Siemens Artis zee Device De… | 2011 |
| * | K090745 | Artis Zee / Zeegos with SW VC14Summary page 1…Product Code: IZI, 892.1600. Predicate Device(s): K<111209: INTEGRATED INNOVA -5S51 SYSTEM OPTION, K<090745 :Siemens Artis zee Device Description: The basis for this submission is a modification of the common… | 2009 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122457 | GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with… | 2013 | 5 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 5 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 IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · IZI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZI
81in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZI
2,171in 2025
MAUDE reports naming product code IZI, 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 | 7 | 28 | 6 | 92 |
| 2008 | 6 | 68 | 52 | 101 |
| 2009 | 2 | — | 18 | 132 |
| 2010 | 2 | — | 11 | 252 |
| 2011 | 4 | 104 | 6 | 377 |
| 2012 | 1 | — | 6 | 77 |
| 2013 | 1 | — | 6 | 58 |
| 2014 | 4 | 111 | 5 | 123 |
| 2015 | 0 | — | 14 | 36 |
| 2016 | 1 | — | 7 | 102 |
| 2017 | 2 | — | 1 | 88 |
| 2018 | 2 | — | 2 | 49 |
| 2019 | 2 | — | 2 | 30 |
| 2020 | 1 | — | 2 | 14 |
| 2021 | 1 | — | 1 | 29 |
| 2022 | 1 | — | 0 | 265 |
| 2023 | 3 | 81 | 0 | 1,204 |
| 2024 | 2 | — | 0 | 1,332 |
| 2025 | 2 | — | 0 | 2,171 |
| 2026 | 2 | — | 1 | — |
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 as stated in the FDA summary.
https://510kreport.com/device/K113034 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113034: GE Innova Solid State Xray Imager Flurosopic 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/K113034
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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