FDA Registration
Active
🇺🇸 United States
DEEPHEALTH
Reg #: 3018733944
·
FEI: 3018733944
·
Expires 2026
Products
5
Proprietary Names
12
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- DEEPHEALTH
- Registration Number
- 3018733944
- FEI Number
- 3018733944
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 212 Elm St.
- City
- Somerville
- State
- MA
- ZIP
- 02144
- Country
- US
Regulatory Submissions
- 510(k) Number
- K243703
Owner / Operator
- Firm Name
- DeepHealth
- Operator Number
- 10081546
- Address
- 212 Elm St.
- City
- Somerville
- State
- MA
- Postal Code
- 02144
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2025-11-18 |
| Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | QDQ | Class 2 | Radiology | No | 2025-11-18 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2022-12-29 |
| Radiological Computer-Assisted Prioritization Software For Lesions | QFM | Class 2 | Radiology | No | 2021-04-22 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2023-09-07 |
Proprietary Names
TechLive
Saige-Dx
Saige-Density
SmartMammo Density
Saige-Q
SmartMammoDx
ThinQ
Brain Age
Saige-Assure
Breast Density
Breast Arterial Calcification (BAC)
ProFound Pro
Establishment Types
Manufacture Medical Device