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

Name: FDA 510(k) clearance K190496
Creator: U.S. Food and Drug Administration
Published: 2019-04-24

Substantially Equivalent

Cefla S.C.

FDA 510(k) clearance K190496 for hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS, Substantially Equivalent on 2019-04-24. 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: 2019-02-28
Decision date: 2019-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Imola (Bo), IT

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.