510(k) · Cleared
Recalled · Class II · 2019Integrated Innova - S5I System Option
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 Jul 26, 2011 as substantially equivalent to K061163 (Ge Medical Systems, LLC, 2006) after an 88-day review. Its family tree reaches back 8 generations to 1989. 8 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 26, 2011
- Review
- 88 days
- Class
- Class II
- Product code
- IZI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 8 generations to K890348 (1989). 18 ancestors in all. 8 later devices descend from it, 3 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 deviceK111209 Integrated Innova - S5I System OptionGE Healthcare · 2011
- Descendant · cites it directly · 6 of its ownK113403 GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemGE Medical Systems SCS · 2012 · Recalled
- Descendant · cites it directly · 6 of its ownK113034 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
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K113403GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemGE Medical Systems SCS · 2012 · cites it directly6descendants
- K113034GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare · 2011 · cites it directly6descendants
- 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
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) | K111209 | Integrated Innova - S5I System Option | GE Healthcare | 2011 | — |
| +1 | K113403 | GE Discovery Igs Angiographic,Fluoroscopic X-Ray System | GE Medical Systems SCS | 2012 | 4 |
| +1 | 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 |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K061163 | Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ…Summary page 1…s: 121 SYSTEM. X-RAY, ANGIOGRAPHIC Product Code: MOB :SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGERI Predicate Device(s): K(061163 : INNOVA xlx1'Q &X1O001 systems with IVUS option Device Description: The integrated INNOVA - ssi system optio… | 2006 |
What descends from it? (8)
3 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-1199-2019 | 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. |
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 1.6 years on median.
- 14 of the 18 ancestors have a recall of any class.
- Of its descendants, K113403 (GE Medical Systems SCS, 2012) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K061163.
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. The Integrated Innova - s5i system option is indicated for use in conjunction with single plane and biplane angiographic X-ray systems. The Integrated Innova - s5i system option simplifies the clinical workflow associated with the use of Volcano s5i…
Read the full statement (127 words)
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.
The Integrated Innova - s5i system option is indicated for use in conjunction with single plane and biplane angiographic X-ray systems.
The Integrated Innova - s5i system option simplifies the clinical workflow associated with the use of Volcano s5i systems by:
(1) automatically synchronizing the patient demographic and medical exam information (patient name, date of birth, etc.) from angiographic X-ray systems with Volcano s5i systems,
(2) providing a remote access to commonly used Volcano s5i system functions from the angiographic X-ray systems user interface,
(3) displaying the Volcano s5i systems output on the monitor display solutions of the angiographic X-ray systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111209 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111209: Integrated Innova - S5I System Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111209
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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