K251198
- 510(k) number
- K251198
- Device name
- HyperVue Software
- Applicant
- Spectrawave, Inc. MA · US
- Product code
- NQQ — System, Imaging, Optical Coherence Tomography (Oct)
- Decision date
- 2025-07-16
- Date received
- 2025-04-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K251198.pdf
Official FDA record: K251198
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.