Spectrawave, Inc.
Bedford, MA, US
SPECTRAWAVE, INC. appears in FDA device records in Bedford, MA. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Spectrawave, Inc. between 2023 and 2025. The busiest year on record is 2025, with 4. The most recent is 2025, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2023 | 2 |
| 2025 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253101 | HyperVue™ Imaging System - Integrated | NQQ | Substantially Equivalent | |
| K251355 | X1-FFR | QHA | Substantially Equivalent | |
| K251198 | HyperVue™ Software | NQQ | Substantially Equivalent | |
| K243016 | Starlight Imaging Catheter | NQQ | Substantially Equivalent | |
| K230691 | HyperVue™ Imaging System | NQQ | Substantially Equivalent | |
| K221257 | SpectraWAVE Imaging System | NQQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3017654247 | 3017654247 | SPECTRAWAVE, INC. | 12 Oak Park Drive, Bedford, MA 01730 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OGZCatheter, Intravascular, Plaque Morphology Evaluation
- ORDOptical Coherence Tomography, Intravascular Catheter
- LLZSystem, Image Processing, Radiological
- NQQSystem, Imaging, Optical Coherence Tomography (Oct)
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- QHAX-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain