Identity
- Trade Name
- mMR Head set FDA UDI
- Generic Name
- PET/MRI system FDA UDI
- Device Name
- Contains Medical Device Mat. 10835409 (GTIN:04056869015446) FDA UDI
- Model / Reference
- 10185548 FDA UDI
- Description
- Contains Medical Device Mat. 10835409 (GTIN:04056869015446) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056869014760 FDA UDI
- 510(k) Number
- K133226 FDA UDI
- FDA Product Code
- OUO FDA UDI
- GMDN Term
- PET/MRI system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1200 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: PET/MRI system
mMR Head set by Siemens Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as PET/MRI system.
- special purpose coil 4 — Siemens Shenzhen Magnetic Resonance Ltd. · Class II
- 3T Loop 7 cm MR coil — Siemens Healthcare · Class II
- mMR Body coil — Siemens Healthcare · Class II
- 3T PA matrix MR coil — Siemens Healthcare · Class II
- mMR Spine Matrix coil set — Siemens Healthcare · Class II
- mMR Body coil set — Siemens Healthcare · Class II
- 3T Loop 11 cm MR coil kit — Siemens Healthcare · Class II
- 3T Loop 4 cm MR coil — Siemens Healthcare · Class II
Cleared under the same submission
K133226 also covers:
- 3T Loop 4 cm MR coil kit — Siemens Healthcare
- 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/Neck Matrix coil — Siemens Healthcare
- mMR Head/Neck coil set — Siemens Healthcare
- mMR Spine Matrix coil set — Siemens Healthcare
- mMR Spine 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare
Sources (1)
- FDA UDI 95622df1-b1ff-41bc-9b88-7585babb8504 35 fields · synced May 30, 2026