# K181403: Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Nov 2, 2018 after 157 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K890348 (1989). 59 ancestors in all.
3 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)
- K122457: GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with Cathlab Frontiers Solutions, GE Healthcare (2013) Summary page 5.
- K133278: Discovery Igs 740, GE Medical Systems SCS (2014) Summary page 5.

## Most influential descendants
- 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 18, 2024 · Class II · Z-1777-2024: GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS produ
- Mar 18, 2024 · Class II · Z-1783-2024: GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS produ
- Mar 18, 2024 · Class II · Z-1782-2024: GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS produ
- Mar 18, 2024 · Class II · Z-1778-2024: GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS produ
- Apr 19, 2021 · Class II · Z-1864-2021: The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two unequal image parts within the monitor display screen.
- Mar 15, 2019 · Class II · Z-1201-2019: 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

## 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/K181403
Methodology: https://510kreport.com/methodology