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MAGNETOM Flow.Ace - MAGNETOM Flow.Ace

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K260265Ref 11571247Model MDR_02_IIa_SZN G MR ERL H 127_ACDV_MagnetomRef 11571248Ref 11571091Model MDR_02_SPPP_IIa_SZN G MR_Comb.MagnetomRef 11571132

by Siemens Shenzhen Magnetic Resonance Ltd.

Identity

Trade Name
MAGNETOM Flow.Ace 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
MDR_02_SPPP_IIa_SZN G MR_Comb.Magnetom EUDAMED
Model / Reference
11571247 EUDAMEDFDA UDI
11571248 EUDAMEDFDA UDI
MDR_02_IIa_SZN G MR ERL H 127_ACDV_Magnetom EUDAMED
MDR_02_SPPP_IIa_SZN G MR_Comb.Magnetom EUDAMED
11571091 EUDAMED
11571132 EUDAMED

Identifiers

Primary DI / UDI-DI
04056869996202 EUDAMEDFDA UDI
04056869996219 EUDAMEDFDA UDI
04056869999678 EUDAMED
04068151051766 EUDAMED
Basic UDI-DI
0405686900126US EUDAMED
0405686900131UK EUDAMED
510(k) Number
K260265 FDA 510(k)
K250436 FDA UDI
FDA Product Code
LNH FDA 510(k)FDA UDI
MOS FDA UDI
LNI 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 Flow.Ace FDA 510(k)FDA UDIEUDAMED
MAGNETOM Flow.Plus 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)
Medical Purpose
Combined use of the listed medical devices to enhance MRI diagnostic imaging in accordance with the respective instructions for use of the individual EUDAMED
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
MRI Safety
MR Safe FDA UDI

MAGNETOM Flow.Ace - MAGNETOM Flow.Ace by Siemens Shenzhen Magnetic Resonance Ltd. — Class II — MDR, FDA_510K — listed in FDA 510(k), FDA GUDID, EUDAMED — 2…

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 (7)

  • FDA 510(k) K260265 24 fields · synced Oct 6, 2026
  • FDA UDI 60d56808-8a78-498a-ac2d-865f1795c787 34 fields · synced May 29, 2026
  • FDA UDI db3bb8ea-6750-430b-85e2-ff1d1d08a3da 34 fields · synced May 30, 2026
  • EUDAMED 6aad92a3-65e2-4c3c-b354-0a0814b7a567 61 fields · synced Jul 9, 2026
  • EUDAMED f4043391-2ae3-426e-ba55-5b7a7fab4266 61 fields · synced Jul 13, 2026
  • EUDAMED 0690c120-a5e0-435b-8c32-53323fcd7a7f 61 fields · synced Jul 13, 2026
  • EUDAMED 89d5df16-d03b-45e7-9761-92484cd05aff 61 fields · synced Aug 3, 2026