FDA Registration
Active
🇧🇪 Belgium
icobrain aria
Reg #: 3013427569
·
FEI: 3013427569
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- icometrix
- Registration Number
- 3013427569
- FEI Number
- 3013427569
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Kolonel Begaultlaan 1b / 12
- City
- Leuven Vlaams Brabant
- Country
- BE
Regulatory Submissions
- 510(k) Number
- K240712
Owner / Operator
- Firm Name
- icometrix
- Operator Number
- 10052535
- Address
- Kolonel Begaultlaan 1b / 12
- City
- Leuven
- State
- Vlaams Brabant
- Postal Code
- 3012
- Country
- BE
- Correspondent
- Dirk Smeets
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radiological Computer Assisted Detection/Diagnosis Software For Fracture | QBS | Class 2 | Radiology | No | 2024-12-05 |
Proprietary Names
icobrain aria
Establishment Types
Manufacture Medical Device