# K251199: Allia Moveo

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems SCS
- Decided: Dec 9, 2025 after 235 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K890348 (1989). 61 ancestors in all.
No later device cites it as a predicate yet.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232344: Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR, GE Medical Systems SCS (2023) Summary page 6.

## Recalls of this device
- Apr 20, 2026 · Class II · Z-2318-2026: 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

## 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/K251199
Methodology: https://510kreport.com/methodology