K243016
- 510(k) number
- K243016
- Device name
- Starlight Imaging Catheter
- Applicant
- Spectrawave, Inc. MA · US
- Product code
- NQQ — System, Imaging, Optical Coherence Tomography (Oct)
- Decision date
- 2025-03-20
- Date received
- 2024-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K243016.pdf
Official FDA record: K243016
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.