FDA Registration
Active
🇺🇸 United States
MammoScreen QC
Reg #: 3016759115
·
FEI: 3016759115
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Therapixel Inc.
- Registration Number
- 3016759115
- FEI Number
- 3016759115
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1700 W Irving Park Rd ST. 209A
- City
- Chicago
- State
- IL
- ZIP
- 60613
- Country
- US
Owner / Operator
- Firm Name
- THERAPIXEL
- Operator Number
- 10071453
- Address
- 1 Impasse Reille
- City
- Paris
- State
- FR-75
- Postal Code
- 75014
- Country
- FR
- Correspondent
- Pierre Fillard
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Quality-Assurance, Radiologic | LHO | Class 1 | Radiology | No | 2024-11-14 |
Proprietary Names
MammoScreen QC
Genius AI Detection PRO Image Quality for Quality
Establishment Types
Complaint File Establishment per 21 CFR 820.198