# K232344: Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR

- Pathway: 510(k) (Special)
- Applicant: GE Medical Systems SCS
- Decided: Oct 11, 2023 after 68 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K890348 (1989). 60 ancestors in all.
1 later device descends from it; 1 cites 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)
- K181403: Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR, GE Healthcare (2018) Summary page 5.

## Most influential descendants
- K251199: Allia Moveo (2025), 0 descendants of its own

## Recalls of this device
- Apr 20, 2026 · Class II · Z-2317-2026: GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service p
- Apr 20, 2026 · Class II · Z-2315-2026: GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service p
- Apr 20, 2026 · Class II · Z-2314-2026: GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service p
- Apr 20, 2026 · Class II · Z-2316-2026: GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service p
- Mar 18, 2024 · Class II · Z-1779-2024: 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-1780-2024: 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-1781-2024: 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

## 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/K232344
Methodology: https://510kreport.com/methodology