# K111209: Integrated Innova - S5I System Option

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Jul 26, 2011 after 88 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K890348 (1989). 18 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061163: Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ, Innova 2100IQ with Innova Ivus Opt, Ge Medical Systems, LLC (2006) Summary page 1.

## Most influential descendants
- K113403: GE Discovery Igs Angiographic,Fluoroscopic X-Ray System (2012), 6 descendants of its own
- K113034: GE Innova Solid State Xray Imager Flurosopic X Ray System (2011), 6 descendants of its own
- K122457: GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with Cathlab Frontiers Solutions (2013), 5 descendants of its own
- K133278: Discovery Igs 740 (2014), 4 descendants of its own
- K181403: Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR (2018), 3 descendants of its own

## Recalls of this device
- Mar 15, 2019 · Class II · Z-1199-2019: 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 simultaneo
- Mar 29, 2018 · Class II · Z-2387-2018: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K111209
Methodology: https://510kreport.com/methodology