Identity
- Trade Name
- Body 18 MR Coil 3T FDA UDI
- Generic Name
- Full-body MRI system, superconducting magnet FDA UDI
- Device Name
- MRI Coil FDA UDI
- Model / Reference
- 10835325 FDA UDI
- Description
- MRI Coil FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056869015415 FDA UDI
- FDA Product Code
- LNH FDA UDILNI FDA UDIMOS 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Full-body MRI system, superconducting magnet
Body 18 MR Coil 3T by Siemens Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Full-body MRI system, superconducting magnet.
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- Magnetic Resonance (MR) Systems — Beijing Wandong Medical Technology Co., Ltd. · Class IIa
- Magnetic Resonance (MR) Systems — Beijing Wandong Medical Technology Co., Ltd. · Class IIa
Cleared under the same submission
K151579 also covers:
- 1, 5T Loop 11 cm MR coil kit — Siemens Healthcare
- 1.5T Loop 11cm MR coil — Siemens Healthcare
- 1.5T Loop 4 cm MR coil — Siemens Healthcare
- 1.5T Loop 4 cm MR coil kit — Siemens Healthcare
- 1.5T Loop 7 cm MR coil — Siemens Healthcare
- 1.5T Loop 7 cm MR coil kit — Siemens Healthcare
- 3T Loop 4 cm MR coil kit — Siemens Healthcare
- Body 18 MR Coil 1.5T — Siemens Healthcare
- Body 18 MR Coil set 1.5T 098 — Siemens Healthcare
- Body 18 MR Coil set 3T 098 — Siemens Healthcare
- Body 18 long MR coil 1.5T — Siemens Healthcare
- Body 18 long MR coil 3T — Siemens Healthcare
K153343 also covers:
- 1, 5T Loop 11 cm MR coil kit — Siemens Healthcare
- 1.5T Loop 11cm MR coil — Siemens Healthcare
- 1.5T Loop 4 cm MR coil — Siemens Healthcare
- 1.5T Loop 4 cm MR coil kit — Siemens Healthcare
- 1.5T Loop 7 cm MR coil — Siemens Healthcare
- 1.5T Loop 7 cm MR coil kit — Siemens Healthcare
- 3T Loop 4 cm MR coil kit — Siemens Healthcare
- Body 18 MR Coil 1.5T — Siemens Healthcare
- Body 18 MR Coil set 1.5T 098 — Siemens Healthcare
- Body 18 MR Coil set 3T 098 — Siemens Healthcare
- Body 18 long MR coil 1.5T — Siemens Healthcare
- Body 18 long MR coil 3T — Siemens Healthcare
K170396 also covers:
- 3T Loop 4 cm MR coil kit — Siemens Healthcare
- Body 18 MR Coil set 3T 098 — Siemens Healthcare
- Body 18 long MR coil 3T — Siemens Healthcare
- Body 18 long MR set of coils 3T — Siemens Healthcare
- Body 30 MR coil 3T — Siemens Healthcare
- Body 30 MR coil set 3T — Siemens Healthcare
- Flex Large 18 Coil Kit 3T — Siemens Healthcare
- Flex Large 18 Coil Kit 3T — Siemens Healthcare
- Flex Small 18 Coil 3T — Siemens Healthcare
- Flex Small 18 Coil Kit 3T — Siemens Healthcare
- Flex Small 4 MR coil 3T — Siemens Healthcare
- Flex small 4 MR coil set 3T — Siemens Healthcare
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 |
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Manufacturer
- Manufacturer
- Siemens Healthcare
Sources (1)
- FDA UDI 8dc7a7e7-13e1-4524-91b0-d03b69dfc9b2 35 fields · synced May 30, 2026