# K122457: GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with Cathlab Frontiers Solutions

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Jan 2, 2013 after 142 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 20 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K890348 (1989). 57 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113034: GE Innova Solid State Xray Imager Flurosopic X Ray System, GE Healthcare (2011) Summary page 6.
- K111209: Integrated Innova - S5I System Option, GE Healthcare (2011) Summary page 6.
- K113403: GE Discovery Igs Angiographic,Fluoroscopic X-Ray System, GE Medical Systems SCS (2012) Summary page 6.

## Most influential descendants
- 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
- K232344: Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR (2023), 1 descendant of its own
- K251199: Allia Moveo (2025), 0 descendants of its own
- K243446: 3DXR (2025), 0 descendants of its own

## Recalls of this device
- Mar 15, 2019 · Class II · Z-1200-2019: 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.
- Mar 29, 2018 · Class II · Z-2386-2018: 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.
- Dec 18, 2015 · Class II · Z-0763-2016: GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor.
- Nov 13, 2015 · Class II · Z-0414-2016: GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems.
- Nov 13, 2015 · Class II · Z-0413-2016: GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems .
- May 29, 2015 · Class II · Z-1984-2015: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Dis
- May 29, 2015 · Class II · Z-1981-2015: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Dis
- May 29, 2015 · Class II · Z-1977-2015: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Dis
- May 29, 2015 · Class II · Z-1983-2015: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Dis
- May 29, 2015 · Class II · Z-1985-2015: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Dis
- May 29, 2015 · Class II · Z-1974-2015: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Dis
- May 29, 2015 · Class II · Z-1980-2015: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Dis
- May 29, 2015 · Class II · Z-1978-2015: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Dis
- May 29, 2015 · Class II · Z-1982-2015: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Dis
- May 29, 2015 · Class II · Z-1976-2015: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Dis
- May 29, 2015 · Class II · Z-1973-2015: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Dis
- May 29, 2015 · Class II · Z-1979-2015: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Dis
- Sep 4, 2014 · Class II · Z-0451-2015: Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism.
- Nov 15, 2013 · Class II · Z-0853-2014: GE Healthcare has recently become aware of a potential safety issue with respect to IGS 630 Imaging Systems. While performing fluoroscopy on a biplane fluoroscopy unit, there is a potential for loss o

## Indications for use
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. . The Cathlab Frontiers solutions are indicated for use in conjunction with single plane and biplane GE angiographic X-ray systems and imaging / data medical devices used in interventional and surgical cathlab environments and cleared for commercial distribution. The Cathlab Frontiers solutions are integrated GE angiographic X-ray and imaging / data medical devices that simplify the end-to-end clinical workflow in the cathlab by implementing: - (1) communication protocols for exchanging and automatically synchronizing patient, exam, system, and image information between the angiographic X-ray systems and the imaging / data medical devices, (2) communication protocols for the control of imaging / data medical device functions from the angiographic X-ray systems user interface, (3) interfaces for displaying the imaging / data medical device output on the monitor display solutions of the GE angiographic X-ray systems.

Source page: https://510kreport.com/device/K122457
Methodology: https://510kreport.com/methodology