510(k) K190496— hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS

Substantially Equivalent

Cefla S.C.

Clearance details

Applicant: Cefla S.C.
Product code: Code OAS
Advisory panel: Radiology
Date received: 2019-02-28
Decision date: 2019-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Imola (Bo), IT

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