← Back to catalogue
MAGNETOM Flow.Plus
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 11571313Model MDR_02_IIa_SZN G MR ERL H 127_ACDV_Magnetom
Identity
- Trade Name
- MAGNETOM Flow.Plus EUDAMEDFDA UDI
- Generic Name
- Full-body MRI system, superconducting magnet FDA UDI
- Device Name
- MDR_02_IIa_SZN G MR ERL H 127_ACDV_Magnetom EUDAMED
- Model / Reference
- 11571313 EUDAMEDFDA UDIMDR_02_IIa_SZN G MR ERL H 127_ACDV_Magnetom EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056869997933 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686900126US EUDAMED
- 510(k) Number
- K250436 FDA UDI
- FDA Product Code
- LNH FDA UDIMOS FDA UDILNI FDA UDI
- EMDN Code
- Z11050104 CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T EUDAMED
- GMDN Term
- Full-body MRI system, superconducting magnet FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- Bulgaria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
MR Safe FDA UDI
MAGNETOM Flow.Plus by Siemens Shenzhen Magnetic Resonance Ltd. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K250436 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Shenzhen Magnetic Resonance Ltd.
Sources (2)
- FDA UDI b0d8993c-6087-446a-84d1-1b7a73ae1613 34 fields · synced Oct 6, 2026
- EUDAMED 7149b815-93b4-432c-949e-f4e22a9cf5d3 61 fields · synced Jul 21, 2026