BoneView— 510(k) K212365

Substantially Equivalent

Gleamer

FDA 510(k) clearance K212365 for BoneView, Substantially Equivalent on 2022-03-01. Applicant: Gleamer.

Clearance details

Applicant: Gleamer
Product code: Code QBS
Advisory panel: Radiology
Date received: 2021-07-30
Decision date: 2022-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint Mandé, FR

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