K240094

Substantially Equivalent

LumiNE US; Lumi

Applicant: Augmedit B.V.
Product code: QIH
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 ↗

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