hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS— 510(k) K223794

Substantially Equivalent

Cefla 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..

Clearance details

Applicant: Cefla S.C.
Product code: Code OAS
Advisory panel: Radiology
Date received: 2022-12-19
Decision date: 2023-01-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Imola (Bo), IT

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