Spectrawave, Inc.
Spectrawave, Inc. appears in FDA public data with 0 recalls, 6 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on December 15, 2025.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K253101 | HyperVue Imaging System - Integrated | December 15, 2025 |
| K251355 | X1-FFR | October 17, 2025 |
| K251198 | HyperVue Software | July 16, 2025 |
| K243016 | Starlight Imaging Catheter | March 20, 2025 |
| K230691 | HyperVue Imaging System | June 7, 2023 |
| K221257 | SpectraWAVE Imaging System | February 28, 2023 |