Identity
- Trade Name
- MAGNETOM C! FDA UDI
- Generic Name
- Full-body MRI system, permanent magnet FDA UDI
- Device Name
- MRI Scanner FDA UDI
- Model / Reference
- 10498833 FDA UDI
- Description
- MRI Scanner FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056869020495 FDA UDI
- 510(k) Number
- K082331 FDA UDI
- FDA Product Code
- LNH FDA UDIMOS FDA UDI
- GMDN Term
- Full-body MRI system, permanent 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, permanent magnet
Magnetom C! 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, permanent magnet.
- Promaxo MRI System — Promaxo, Inc. · Class II
- ANKE — Shenzhen Anke High-Tech Co., Ltd. · Class II
- PICA Whole-body MRI System — Time Medical Systems, Inc. · Class II
- Promaxo MRI System — Promaxo, Inc. · Class II
- Extremity L MR Coil Kit — Siemens Shenzhen Magnetic Resonance Ltd. · Class II
- Breast coil c035 — Siemens Shenzhen Magnetic Resonance Ltd. · Class II
- Body Spine Array M MR Coil Kit — Siemens Shenzhen Magnetic Resonance Ltd. · Class II
- Extremity Array Coil S — Siemens Shenzhen Magnetic Resonance Ltd. · Class II
Cleared under the same submission
K082331 also covers:
- BODY SPINE LOWER MR COIL PART — Siemens Shenzhen Magnetic Resonance Ltd.
- Body Spine Array Coil XL — Siemens Shenzhen Magnetic Resonance Ltd.
- Body Spine Array L MR Coil Kit — Siemens Shenzhen Magnetic Resonance Ltd.
- Body Spine Array M C035 — Siemens Shenzhen Magnetic Resonance Ltd.
- Body Spine Array M MR Coil Kit — Siemens Shenzhen Magnetic Resonance Ltd.
- Body Spine Array S C035 — Siemens Shenzhen Magnetic Resonance Ltd.
- Body Spine Array S MR Coil Kit — Siemens Shenzhen Magnetic Resonance Ltd.
- Body Spine Array XXL C035 — Siemens Shenzhen Magnetic Resonance Ltd.
- Body Spine Array XXL MR Coil Kit — Siemens Shenzhen Magnetic Resonance Ltd.
- Body spine array L C035 — Siemens Shenzhen Magnetic Resonance Ltd.
- Body spine array XL kit — Siemens Shenzhen Magnetic Resonance Ltd.
- Breast coil c035 — Siemens Shenzhen Magnetic Resonance Ltd.
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 Shenzhen Magnetic Resonance Ltd.
Sources (1)
- FDA UDI 1a22f83b-888f-42f2-a8e3-dfd9cdbd64d7 35 fields · synced May 31, 2026