hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS— 510(k) K223794
Substantially EquivalentCefla S.C.
FDA 510(k) clearance K223794 for hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS, Substantially Equivalent on 2023-01-17. Applicant: Cefla S.C.. Device class: 2.
Clearance details
- Applicant
- Cefla S.C.
- Product code
- Code OAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Imola (Bo), IT
Recent devices under product code OAS
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Data sourced from openFDA. This site is unofficial and independent of the FDA.