Cleared Traditional

Allia Moveo

K251199 · GE Medical Systems SCS · Radiology

Dec 2025

Decision

235d

Days

Class 2

Risk

About This 510(k) Submission

K251199 is an FDA 510(k) clearance for the Allia Moveo, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by GE Medical Systems SCS (Buc, FR). The FDA issued a Cleared decision on December 9, 2025, 235 days after receiving the submission on April 18, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K251199 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 18, 2025
Decision Date	December 09, 2025
Days to Decision	235 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OWB — Interventional Fluoroscopic X-ray System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.1650
Definition	Interventional Fluoroscopy