Company · US
Spectrawave, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2023 to 2025. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 15, 2025 | K253101 | HyperVue Imaging System - Integrated Spectrawave, Inc. | NQQ |
| Oct 17, 2025 | K251355 | X1-FFR Spectrawave, Inc. | QHA |
| Jul 16, 2025 | K251198 | HyperVue Software Spectrawave, Inc. | NQQ |
| Mar 20, 2025 | K243016 | Starlight Imaging Catheter Spectrawave, Inc. | NQQ |
| Jun 7, 2023 | K230691 | HyperVue Imaging System Spectrawave, Inc. | NQQ |
| Feb 28, 2023 | K221257 | SpectraWAVE Imaging System Spectrawave, Inc. | NQQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||