K253101 is an FDA 510(k) clearance for the HyperVue™ Imaging System - Integrated. This device is classified as a System, Imaging, Optical Coherence Tomography (oct) (Class II - Special Controls, product code NQQ).
Submitted by Spectrawave, Inc. (Bedford, US). The FDA issued a Cleared decision on December 15, 2025, 82 days after receiving the submission on September 24, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 892.1560. This Device Uses Back-reflected Light To Create Two-dimensional Images Versus Back-reflected Sound Waves As Are Used In Ultrasound Imaging..
| 510(k) Number | K253101 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2025 |
| Decision Date | December 15, 2025 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | NQQ - System, Imaging, Optical Coherence Tomography (oct) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1560 |
| Definition | This Device Uses Back-reflected Light To Create Two-dimensional Images Versus Back-reflected Sound Waves As Are Used In Ultrasound Imaging. |