LumiNE US— 510(k) K240094

Substantially Equivalent

Augmedit B.V.

FDA 510(k) clearance K240094 for LumiNE US, Substantially Equivalent on 2024-09-10. Applicant: Augmedit B.V.. Device class: 2.

Clearance details

Device name as filed: LumiNE US; Lumi
Applicant: Augmedit B.V.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-01-12
Decision date: 2024-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naarden, NL

Download summary PDF View on FDA.gov ↗

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