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MAGNETOM Free.Max +1 more model

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K251822Ref 11408425Model MDR_02_IIa_SZN G MR ERL H 127_ACDV_Magnetom

by Siemens Shenzhen Magnetic Resonance Ltd.

Identity

Trade Name
MAGNETOM Free.Max 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
MRI Scanner FDA UDI
Model / Reference
11408425 EUDAMEDFDA UDI
MDR_02_IIa_SZN G MR ERL H 127_ACDV_Magnetom EUDAMED
Description
MRI Scanner FDA UDI

Identifiers

Primary DI / UDI-DI
04056869281742 EUDAMEDFDA UDI
Basic UDI-DI
0405686900126US EUDAMED
510(k) Number
K251822 FDA 510(k)
FDA Product Code
LNH FDA 510(k)FDA UDI
MOS 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
Models / Variants
MAGNETOM Free.Max FDA 510(k)FDA UDIEUDAMED
MAGNETOM Free.Star FDA 510(k)FDA UDIEUDAMED

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 892.1000 FDA 510(k)
Regulation Number
892.1000 FDA 510(k)FDA UDI
Market of Registration
Germany EUDAMED
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

MAGNETOM Free.Max +1 more model by Siemens Shenzhen Magnetic Resonance Ltd. — Class II — MDR, FDA_510K — listed in FDA 510(k), FDA GUDID, EUDAMED — 2 models

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Siemens Shenzhen Magnetic Resonance Ltd.
FDA Applicant
Siemens Shenzhen Magnetic Resonance , Ltd.

Sources (3)

  • FDA 510(k) K251822 24 fields · synced Oct 7, 2026
  • FDA UDI d5802dae-5bd3-4228-8376-57ea153d313a 34 fields · synced May 30, 2026
  • EUDAMED 288c3c2e-413b-440a-b6b0-ea9ff4f6d89a 61 fields · synced Jul 8, 2026