Identity
- Trade Name
- Contour M Coil Set FDA UDI
- Generic Name
- Full-body MRI system, superconducting magnet FDA UDI
- Model / Reference
- 11407677 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056869281926 FDA UDI
- FDA Product Code
- MOS FDA UDI
- GMDN Term
- Full-body MRI system, superconducting magnet FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Full-body MRI system, superconducting magnet
Contour M Coil Set by Siemens Shenzhen Magnetic Resonance Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Full-body MRI system, superconducting magnet.
- MAGNETOM Sola Fit — Siemens Healthcare · Class II
- Head/Neck 64 CS Coil 3T — Siemens Healthcare · Class II
- 1.5T HDxt Upgrade Kit — GE MEDICAL SYSTEMS, INC. · Class IIa
- Flex small 4 MR coil set 3T — Siemens Healthcare · Class II
- InVision 1.5 Surgical Theatre — IMRIS Imaging, Inc. · Class II
- Head/Neck 20 MR Coil 1.5T — Siemens Healthcare · Class II
- Head 32 MR Coil Set 3T 098 — Siemens Healthcare · Class II
- Flex large 4 MR coil set 3T — Siemens Healthcare · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Shenzhen Magnetic Resonance Ltd.
Sources (1)
- FDA UDI e4403c01-2297-4acf-b637-d2e1251907ca 33 fields · synced Jun 1, 2026