# K133278: Discovery Igs 740

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems SCS
- Decided: Apr 24, 2014 after 182 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K890348 (1989). 58 ancestors in all.
4 later devices descend from it; 1 cites 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)
- K122457: GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with Cathlab Frontiers Solutions, GE Healthcare (2013) Summary page 1.
- K113403: GE Discovery Igs Angiographic,Fluoroscopic X-Ray System, GE Medical Systems SCS (2012) Summary page 2.

## Most influential descendants
- 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 29, 2018 · Class II · Z-2388-2018: 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.
- Apr 15, 2016 · Class II · Z-1707-2016: 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.
- May 29, 2015 · Class II · Z-1975-2015: 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
- Dec 10, 2014 · Class II · Z-0966-2015: Potential unintentional system motion or rotation due to a positioning user interface issue with Discovery IGS 730 and 740 products.
- Sep 4, 2014 · Class II · Z-0452-2015: 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.

## 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.

Source page: https://510kreport.com/device/K133278
Methodology: https://510kreport.com/methodology