K242924
- 510(k) number
- K242924
- Device name
- OPXION Optical Skin Viewer (OPXSV1-01F)
- Applicant
- Opxion Technology, Inc. TW
- Product code
- NQQ — System, Imaging, Optical Coherence Tomography (Oct)
- Decision date
- 2025-06-23
- Date received
- 2024-09-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K242924.pdf
Official FDA record: K242924
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.