FDA Registration
Active
🇺🇸 United States
SPECTRAWAVE, INC.
Reg #: 3017654247
·
FEI: 3017654247
·
Expires 2026
Products
6
Proprietary Names
5
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- SPECTRAWAVE, INC.
- Registration Number
- 3017654247
- FEI Number
- 3017654247
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 12 Oak Park Drive
- City
- Bedford
- State
- MA
- ZIP
- 01730
- Country
- US
Regulatory Submissions
- 510(k) Number
- K230691
Owner / Operator
- Firm Name
- Philips Medical Systems International BV
- Operator Number
- 2939520
- Address
- Veenpluis 6
- City
- Best
- State
- NL-NOTA
- Postal Code
- 5684PC
- Country
- NL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2026-06-16 |
| Catheter, Intravascular, Plaque Morphology Evaluation | OGZ | Class 2 | Cardiovascular | No | 2026-06-16 |
| Optical Coherence Tomography, Intravascular Catheter | ORD | Class 2 | Cardiovascular | No | 2026-06-16 |
| System, Imaging, Optical Coherence Tomography (Oct) | NQQ | Class 2 | Radiology | No | 2026-06-16 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2026-06-16 |
| X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device | QHA | Class 2 | Radiology | No | 2026-06-16 |
Proprietary Names
HyperVue Imaging System
HyperVue Imaging System - Integrated
HyperVue Software
X1-FFR
Starlight Imaging Catheter
Establishment Types
Manufacture Medical Device