FDA Registration
Active
🇫🇷 France
GE LightSpeed RT 4 CT
Reg #: 3023003446
·
FEI: 3023003446
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BLOCK IMAGING SAS
- Registration Number
- 3023003446
- FEI Number
- 3023003446
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5 rue des Vosges
- City
- Weyersheim Bas-Rhin
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K030420
Owner / Operator
- Firm Name
- Block Imaging SAS
- Operator Number
- 10086857
- Address
- 1845 Cedar Street
- City
- Holt
- State
- MI
- Postal Code
- 48842
- Country
- US
- Correspondent
- Grace Lyon
US Agent
- Business Name
- BLOCK IMAGING INTERNATIONAL
- Contact Name
- Micah Plimpton
- Address
- 1845 Cedar Street
- City
- Holt
- State
- MI
- ZIP
- 48842
- Country
- US
- [email protected]
- Phone
- 517 6688800
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2023-01-26 |
Proprietary Names
GE LightSpeed RT 4 CT
Establishment Types
Export Device to the United States But Perform No Other Operation on Device