FDA Registration
Active
🇺🇸 United States
LumaGEM Scintillation Camera
Reg #: 3005945241
·
FEI: 3005945241
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CMR NAVISCAN CORPORATION
- Registration Number
- 3005945241
- FEI Number
- 3005945241
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2720 Loker Ave W Ste O
- City
- Carlsbad
- State
- CA
- ZIP
- 92010
- Country
- US
Regulatory Submissions
- 510(k) Number
- K993813
Owner / Operator
- Firm Name
- CMR Naviscan Corporation
- Operator Number
- 10045732
- Address
- 2720 Loker Ave W Ste O
- City
- Carlsbad
- State
- CA
- Postal Code
- 92010
- Country
- US
- Correspondent
- Larry Lugo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Camera, Scintillation (Gamma) | IYX | Class 1 | Radiology | No | 2017-12-23 |
Proprietary Names
LumaGEM Scintillation Camera
Establishment Types
Manufacture Medical Device