FDA Device Establishments · JSON-LD · Markdown
FEI 3016851825 · Manufacture Medical Device · Status: Active
| FEI Number | 3016851825 |
|---|---|
| Owner / Operator | Philips Medical Systems International BV (#1217116) |
| Address | B-78/B-79, MIDC, Chakan Industrial area Phase 2, Pune Maharashtra, 410501, IN |
| Mandatory US Agent | Philips |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | MOS |
| Regulation § (21 CFR) | 892.1000 |
| Proprietary names | GE LBS 3T 7CH; Philips 7ch SENSE Breast Coil 1.5T; Coil/ASM/Breast Coil for Echelon; GE HDx 3T 7Ch Biopsy Breast; MammoTrak Interventional Breast Coil 1.5T; Grid Immobilization Plate BBC, Pillar Immobilization Plate BBC, Pillar Immobilization Plate,; Fiducial Holder, Needle Hub Assembly,; Siemens Luminescence 1.5T Breast Coil 16 Ch; GE Excite HDx 1.5T 7ch BBC; Siemens SYMPHONY 1.5T BBC |
Source: openFDA. Public-domain (CC0).