Identity
- Trade Name
- MAGNETOM Skyra FDA UDI
- Generic Name
- Full-body MRI system, superconducting magnet FDA UDI
- Device Name
- MRI Scanner FDA UDI
- Model / Reference
- 10849580 FDA UDI
- Description
- MRI Scanner FDA UDI
Identifiers
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
MAGNETOM Skyra by Siemens Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K140253 also covers:
K141977 also covers:
K142515 also covers:
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 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
K162102 also covers:
K173592 also covers:
K232494 also covers:
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 4fff366e-2564-4933-8fc6-172c3865d1cd 35 fields · synced May 30, 2026