FDA device listing
GE 1.5T 4C PA WRIST (OEM),GE 1.5T HDMR2-VALUE 4C WRIST COIL,GE Excite HD 1.5T 4 Channel Wrist Coil (HRW-GE SIGNA),HD 4CH…
FDA device listing 2052297929 · Philips Medical Systems International BV
Key facts
| Proprietary names | GE 1.5T 4C PA WRIST (OEM),GE 1.5T HDMR2-VALUE 4C WRIST COIL,GE Excite HD 1.5T 4 Channel Wrist Coil (HRW-GE SIGNA),HD 4CH Wrist Array (Receive Only),HIGH RESOLUTION WRIST COIL(Receive Only),MA Wrist Coil |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Premarket submissions | K993477 |
| 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