FDA Registration
Active
🇺🇸 United States
PowerLook Tomo Detection V2
Reg #: 3026970882
·
FEI: 3026970882
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ICAD INC.
- Registration Number
- 3026970882
- FEI Number
- 3026970882
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2 Townsend West, Suite 6
- City
- Nashua
- State
- NH
- ZIP
- 03063
- Country
- US
Regulatory Submissions
- 510(k) Number
- K182373
Owner / Operator
- Firm Name
- iCAD INC.
- Operator Number
- 9054868
- Address
- 2 Townsend West, Suite 6, --
- City
- Nashua
- State
- NH
- Postal Code
- 03063
- Country
- US
- Correspondent
- Melanie Leibowitz
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | QDQ | Class 2 | Radiology | No | 2018-12-11 |
Proprietary Names
PowerLook Tomo Detection V2
ProFound AI
Establishment Types
Manufacture Medical Device