hyperion X5, NewTom GO, X-RADiUS COMPACT— 510(k) K200688
Substantially EquivalentCefla S.C.
FDA 510(k) clearance K200688 for hyperion X5, NewTom GO, X-RADiUS COMPACT, Substantially Equivalent on 2020-04-09. Applicant: Cefla S.C.. Device class: 2.
Clearance details
- Applicant
- Cefla S.C.
- Product code
- Product code OAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Imola, IT
Recent devices under product code OAS
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