FDA Device Establishments · JSON-LD · Markdown
FEI 3016819165 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3016819165 |
|---|---|
| Owner / Operator | THERAPIXEL (#10071453) |
| Address | 455 Promenade des Anglais, Nice Alpes-Maritimes, 06200, FR |
| Mandatory US Agent | VP, Digital Health, AI and Radiology |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | QDQ, QIH |
| Regulation § (21 CFR) | 892.2090, 892.2050 |
| Proprietary names | MammoScreen 4; MammoScreen®; Genius AI® Detection PRO; MammoScreen® 4; MammoScreen |
Source: openFDA. Public-domain (CC0).