K252851
- 510(k) number
- K252851
- Device name
- deepLive (OSP12 + DMS)
- Applicant
- Damae Medical FR
- Product code
- NQQ — System, Imaging, Optical Coherence Tomography (Oct)
- Decision date
- 2025-10-07
- Date received
- 2025-09-08
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K252851.pdf
Official FDA record: K252851
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.