K250684
- 510(k) number
- K250684
- Device name
- OPUSWAVE Dual Sensor Imaging System
- Applicant
- Terumo Cardiovascular Systems Thi Plant MI · US
- Product code
- NQQ — System, Imaging, Optical Coherence Tomography (Oct)
- Decision date
- 2025-07-02
- Date received
- 2025-03-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K250684.pdf
Official FDA record: K250684
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.