FDA Registration
Active
🇺🇸 United States
ScreenPoint Medical, Inc.
Reg #: 3030412475
·
FEI: 3030412475
·
Expires 2026
Products
3
Proprietary Names
4
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- ScreenPoint Medical, Inc.
- Registration Number
- 3030412475
- FEI Number
- 3030412475
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 8 The Green, Suite B
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210404
Owner / Operator
- Firm Name
- ScreenPoint Medical
- Operator Number
- 10059521
- Address
- Mercator II, 7th floor, Toernooiveld 300
- City
- Nijmegen
- State
- Gelderland
- Postal Code
- 6525 EC
- Country
- NL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2020-10-02 |
| Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | QDQ | Class 2 | Radiology | No | 2021-06-23 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2023-12-18 |
Proprietary Names
Transpara SR Converter
Transpara 1.7.y
Transpara
Transpara 1.7.2
Establishment Types
Complaint File Establishment per 21 CFR 820.198