K240094
- 510(k) number
- K240094
- Device name
- LumiNE US; Lumi
- Applicant
- Augmedit B.V. NL
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2024-09-10
- Date received
- 2024-01-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K240094.pdf
Official FDA record: K240094
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.