# K113403: GE Discovery Igs Angiographic,Fluoroscopic X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems SCS
- Decided: Feb 14, 2012 after 89 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K890348 (1989). 55 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111209: Integrated Innova - S5I System Option, GE Healthcare (2011) Summary page 1.
- K090745: Artis Zee / Zeegos with SW VC14, Siemens Medical Solutions USA, Inc. (2009) Summary page 1.

## Most influential descendants
- 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
- 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

## Recalls of this device
- 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.
- Apr 15, 2016 · Class II · Z-1706-2016: 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.
- 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.
- Jun 19, 2013 · Class II · Z-2253-2013: GE Healthcare has recently become aware of a potential safety issue with respect to Discovery IGS 730 Imaging Systems. A patient data management error may prevent the Discovery IGS 730 Imaging System 

## 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. 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/K113403
Methodology: https://510kreport.com/methodology