Identity
- Trade Name
- 1.5T 32-ch Head Coil MR Coil FDA UDI
- Generic Name
- Full-body MRI system, superconducting magnet FDA UDI
- Device Name
- MRI Coil FDA UDI
- Model / Reference
- 10185500 FDA UDI
- Description
- MRI Coil FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056869014593 FDA UDI
- FDA Product Code
- LNI FDA UDIMOS FDA UDILNH 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
1.5T 32-ch Head Coil MR Coil by Siemens Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Full-body MRI system, superconducting magnet.
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- 8 channel wrist coil — Siemens Shenzhen Magnetic Resonance Ltd. · Class II
- 1.5T HDxt Upgrade Kit — GE MEDICAL SYSTEMS, INC. · Class IIa
- Flex Large 8 Coil Set 1.5T — Siemens Shenzhen Magnetic Resonance Ltd. · Class II
- InVision 1.5 Surgical Theatre — IMRIS Imaging, Inc. · Class II
- MAGNETOM Flow.Plus — Siemens Shenzhen Magnetic Resonance Ltd. · Class II
- 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
K121434 also covers:
- 1, 5T Loop 11 cm MR coil kit — Siemens Healthcare
- 1.5T 32-ch Head Coil MR Coil Set — 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 32-ch Head Coil MR Coil — Siemens Healthcare
- 3T 32-ch Head Coil MR Coil Set — Siemens Healthcare
- 3T Head Matrix MR Coil — Siemens Healthcare
- 3T Head Matrix MR coil kit — Siemens Healthcare
- 3T Loop 4 cm MR coil kit — Siemens Healthcare
K123938 also covers:
- 1, 5T Loop 11 cm MR coil kit — Siemens Healthcare
- 1.5T 32-ch Head Coil MR Coil Set — 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 32-ch Head Coil MR Coil — Siemens Healthcare
- 3T 32-ch Head Coil MR Coil Set — Siemens Healthcare
- 3T Head Matrix MR Coil — Siemens Healthcare
- 3T Loop 4 cm MR coil kit — Siemens Healthcare
- 3T Neck Matrix MR Coil — 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 ad49850f-55c4-4a9d-b1ed-8181cdf29d95 35 fields · synced May 30, 2026