Allia Moveo
FDA 510(k) K251199 · GE Medical Systems SCS
510(k) numberK251199
Submission
- Device name
- Allia Moveo
- Applicant
- GE Medical Systems SCS
Buc, FR - Received
- April 18, 2025
- Decision date
- December 9, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Allia Moveo cleared by the FDA?
Allia Moveo (K251199) received a 510(k) decision of Substantially Equivalent on December 9, 2025, 235 days after the submission was received.
What is the product code of K251199?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.