FDA device listing
Achieva TX Interventional Coil 3.0T,AVANTO BIOPSY BREAST ARRAY,Biopsy Breast Coil,BREAST SPEEDER,Coil/ASM/Breast Coil…
FDA device listing 2000003574 · Philips Medical Systems International BV
Key facts
| Proprietary names | Achieva TX Interventional Coil 3.0T,AVANTO BIOPSY BREAST ARRAY,Biopsy Breast Coil,BREAST SPEEDER,Coil/ASM/Breast Coil for Echelon,dS Breast 16ch 1.5T,dS Breast 7ch 1.5T,dS Breast 7ch 3.0T,Fiducial Holder, Needle Hub Assembly,,GE Excite 1.5T 7CH BBC,GE Excite 1.5T 7Ch Biopsy Breast Array,GE Excite HDx 1.5T 7ch BBC,GE Excite HDx 1.5T HDx 7CH BBC,GE HDx 3.0T 7Ch Biopsy Breast,GE LBS 1.5T16CH,GE LBS… |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Premarket submissions | K032576 |
| Product codes | MOS |
| Device names | MOS - Coil, Magnetic Resonance, Specialty |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1000 |
| Review panels | Radiology |
| Registered establishments | Philips Electronics Ltd, Philips Global Business Services LLP, PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Establishment registrations | 3000126629, 3016851825, 3042177665 |
| FEI numbers | 3000126629, 3016851825, 3042177665 |
| Establishment operations | Complaint File Establishment, Specification Developer, Foreign Exporter, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database