myray ProXIma X6— 510(k) K252353

Substantially Equivalent

Cefla S.C.

FDA 510(k) clearance K252353 for myray ProXIma X6, Substantially Equivalent on 2026-03-10. Applicant: Cefla S.C..

Clearance details

Applicant: Cefla S.C.
Product code: Code OAS
Advisory panel: Radiology
Date received: 2025-07-29
Decision date: 2026-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Imola (Bo), IT

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