FDA device listing
dS Breast 16ch 1.5T,dS Breast 16ch 3.0T,MammoTrak Diagnostic Breast Coil 1.5T,Mammotrak Diagnostic Coil 1.5T,Mammotrak…
FDA device listing 1900766916 · Philips Medical Systems International BV
Key facts
| Proprietary names | dS Breast 16ch 1.5T,dS Breast 16ch 3.0T,MammoTrak Diagnostic Breast Coil 1.5T,Mammotrak Diagnostic Coil 1.5T,Mammotrak Diagnostic Coil 3.0T,MammoTrak Interventional Breast Coil 3.0T,Mammotrak Interventional Coil 3.0T,Philips dS Breast 16ch 1.5T,Philips dS Breast 16ch 3.0T,Philips MammoTrak Interventional Breast Coil, 3.0T, 16CH,Philips MammoTrak Interventional Breast Coil, 3.0T, 7CH,Siemens 16 CH… |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Premarket submissions | K072873 |
| 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, 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