Identity
- Trade Name
- 3T Loop 4 cm MR coil kit FDA UDI
- Generic Name
- Full-body MRI system, superconducting magnet FDA UDI
- Device Name
- Contains Medical Device Mat. 10185556 (GTIN:04056869014821) FDA UDI
- Model / Reference
- 08626850 FDA UDI
- Description
- Contains Medical Device Mat. 10185556 (GTIN:04056869014821) FDA UDI
Identifiers
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1200 FDA UDI892.1000 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
3T Loop 4 cm MR coil kit 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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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 — 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
K123938 also covers:
- 1, 5T Loop 11 cm MR coil kit — Siemens Healthcare
- 1.5T 32-ch Head Coil MR Coil — 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 Neck Matrix MR Coil — Siemens Healthcare
K133226 also covers:
- Biograph mMR — Siemens Healthcare
- Flex Large 4 MR coil 3T — Siemens Healthcare
- Flex Small 4 MR coil 3T — Siemens Healthcare
- Flex small 4 MR coil set 3T — Siemens Healthcare
- mMR Body coil — Siemens Healthcare
- mMR Body coil set — Siemens Healthcare
- mMR Head — Siemens Healthcare
- mMR Head set — Siemens Healthcare
- mMR Head/Neck Matrix coil — Siemens Healthcare
- mMR Head/Neck coil set — Siemens Healthcare
- mMR Spine Matrix coil set — Siemens Healthcare
- mMR Spine coil — Siemens Healthcare
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
- Body 18 MR Coil 1.5T — Siemens Healthcare
- Body 18 MR Coil 3T — 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
- Body 18 MR Coil 1.5T — Siemens Healthcare
- Body 18 MR Coil 3T — 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:
- Body 18 MR Coil 3T — 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 f5f90850-3450-467c-89d4-5e7f7e11e527 35 fields · synced May 31, 2026