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Sign in to claim this brandSpectrawave, Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 12 Oak Park Drive, Bedford, MA, 01730
- Website
- spectrawave.com
- —
- —
- [email protected]
- Phone
- 3234016480
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3017654247
- DUNS Number
- 117899663
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Starlight Imaging Catheter | 951 | FDA UDI | Class II | Active |
| HyperVue Imaging System | 931 | FDA UDI | Class II | Active |
| Starlight Imaging Catheter | K243016 | FDA 510(k) | Class II | Active |
| HyperVue™ Imaging System | K230691 | FDA 510(k) | Class II | Active |
| SpectraWAVE Imaging System | K221257 | FDA 510(k) | Class II | Active |
| HyperVue™ Software | K251198 | FDA 510(k) | Class II | Active |
| X1-Ffr | K251355 | FDA 510(k) | Class II | Active |
| HyperVue™ Imaging System - Integrated | K253101 | FDA 510(k) | Class II | Active |
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