FDA Registration
Active
🇺🇸 United States
ICAD INC.
Reg #: 3026970882
·
FEI: 3026970882
·
Expires 2026
Products
7
Proprietary Names
18
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- ICAD INC.
- Registration Number
- 3026970882
- FEI Number
- 3026970882
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2 Townsend West, Suite 6
- City
- Nashua
- State
- NH
- ZIP
- 03063
- Country
- US
Regulatory Submissions
- 510(k) Number
- K203822
- PMA Number
- P010038
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
- B. Nathan Hunt
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 | 2022-05-25 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2022-05-25 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2011-11-08 |
| Analyzer, Medical Image | MYN | Class 2 | Radiology | No | 2007-12-05 |
| Digitizer, Image, Radiological | LMA | Class 2 | Radiology | No | 2008-04-24 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2010-08-19 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2015-06-09 |
Proprietary Names
ProFound AI
ProFound AI V3
ProFound Density
PowerLook Density Assessment V4
PowerLook Density Assessment 3D
PowerLook AMP
SecondLook Digital
Howtek 960
VeraLook Colon CAD
ProFound Detection (V4)
ProFound Detection
ProFound Detection (PFD)
PowerLook Tomo Detection
PowerLook Tomo Detection V2
ProFound AI V2.1
PowerLook Density Assessment 2D
PowerLook Density Assessment
PowerLook Breast Assessment v3.4
Establishment Types
Manufacture Medical Device