FDA device listing
098 1.5T Foot Ankle Coil,098 1.5T Foot Ankle Coil Set,1.5T Shoulder 16 Large,Hand/Wrist 16 1.5T,Hand/Wrist 16 1.5T Coil…
FDA device listing 1475600509 · Siemens Healthineers AG
Key facts
| Proprietary names | 098 1.5T Foot Ankle Coil,098 1.5T Foot Ankle Coil Set,1.5T Shoulder 16 Large,Hand/Wrist 16 1.5T,Hand/Wrist 16 1.5T Coil set,MAGNETOM Altea,MAGNETOM Flow.Elite,MAGNETOM Flow.Neo,MAGNETOM Flow.Rise,MAGNETOM Lumina,MAGNETOM Sola,MAGNETOM Sola Fit,MAGNETOM Viato.Mobile,MAGNETOM Vida,MAGNETOM Vida Fit,Shoulder Shape 16,Shoulder shape 16 coil set 1.5T,Syngo MR XB10A,TX/RX Knee 18,TX/RX Knee 18 Coil Set… |
|---|---|
| Owner/operator | Siemens Healthineers AG |
| Owner/operator number | 8010024 |
| Premarket submissions | K252838 |
| Product codes | LNH, LNI, MOS |
| Device names | LNH - System, Nuclear Magnetic Resonance Imaging, LNI - System, Nuclear Magnetic Resonance Spectroscopic, MOS - Coil, Magnetic Resonance, Specialty |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1000 |
| Review panels | Radiology |
| Registered establishments | Siemens Healthcare Pvt. Ltd., Siemens Healthineers AG, SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. |
| Establishment registrations | 3002808157, 3004754211 |
| FEI numbers | 3002808157, 3004754211 |
| Establishment operations | Contract Manufacturer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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