LumiNE US; Lumi— 510(k) K240094

Substantially Equivalent

Augmedit B.V.

FDA 510(k) clearance K240094 for LumiNE US; Lumi, Substantially Equivalent on 2024-09-10. Applicant: Augmedit B.V..

Clearance details

Applicant: Augmedit B.V.
Product code: Code QIH
Advisory panel: Radiology
Date received: 2024-01-12
Decision date: 2024-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naarden, NL

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