510(k) K251198
K251198 is an FDA 510(k) premarket notification submitted by Spectrawave, Inc. for the device "HyperVue Software". The FDA issued a decision of Substantially Equivalent on July 16, 2025. The device falls under product code NQQ (System, Imaging, Optical Coherence Tomography (Oct)), a Class II device regulated under 21 CFR 892.1560. Spectrawave, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 2025
- Date Received
- April 17, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Optical Coherence Tomography (Oct)
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- SU
- Submission Type
This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.