Radialis PET Camera— 510(k) K214062

Substantially Equivalent

Radialis, Inc.

FDA 510(k) clearance K214062 for Radialis PET Camera, Substantially Equivalent on 2022-02-04. Applicant: Radialis, Inc..

Clearance details

Applicant: Radialis, Inc.
Product code: Code KPS
Advisory panel: Radiology
Date received: 2021-12-27
Decision date: 2022-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thunder Bay, CA

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