Spectrawave, Inc.
FDA 510(k) & PMA Approved Devices — 6 products
Total Devices6
Categories2
Latest Approval2025-12-15
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K253101 | HyperVue Imaging System - Integrated | NQQ | 2025-12-15 | View |
| 510(k) | K251355 | X1-FFR | QHA | 2025-10-17 | View |
| 510(k) | K251198 | HyperVue Software | NQQ | 2025-07-16 | View |
| 510(k) | K243016 | Starlight Imaging Catheter | NQQ | 2025-03-20 | View |
| 510(k) | K230691 | HyperVue Imaging System | NQQ | 2023-06-07 | View |
| 510(k) | K221257 | SpectraWAVE Imaging System | NQQ | 2023-02-28 | View |
No matching devices.