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AI-Rad Companion Brain MR

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K213706Ref 11665399Model MDR_VD_IIa_ERLN_H_127_SAMD_AIRC_MR-B

by Siemens Healthcare GmbH

Identity

Trade Name
AI-Rad Companion Brain MR EUDAMEDFDA UDI
Generic Name
Radiology DICOM image processing application software FDA UDI
Device Name
MDR_VD_IIa_ERLN_H_127_SAMD_AIRC_MR-B EUDAMED
Model / Reference
11665399 EUDAMEDFDA UDI
MDR_VD_IIa_ERLN_H_127_SAMD_AIRC_MR-B EUDAMED

Identifiers

Primary DI / UDI-DI
04056869968278 EUDAMEDFDA UDI
Basic UDI-DI
0405686902008UZ EUDAMED
510(k) Number
K213706 FDA 510(k)
K232305 FDA UDI
FDA Product Code
QIH FDA 510(k)FDA UDI
EMDN Code
Z12040192 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
GMDN Term
Radiology DICOM image processing application software FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)FDA UDI
Special Device Type
Software EUDAMED
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

Yes

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

AI-Rad Companion Brain MR by Siemens Healthcare GmbH — Class II — MDR, FDA_510K — listed in FDA 510(k), FDA GUDID, EUDAMED — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Siemens Healthcare GmbH

Sources (3)

  • FDA 510(k) K213706 24 fields · synced Oct 6, 2026
  • FDA UDI 6a25b91e-5f74-49aa-b936-88e84280854e 34 fields · synced May 30, 2026
  • EUDAMED 5ff8560f-0f71-45e5-834d-0675d01d1bd2 61 fields · synced Jul 16, 2026