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SyMRI 12

by SyntheticMR AB Sweden EUDAMED510(k)

Ref 0004510(k) K191036

Product code LNHEMDN Z11050182

Overview

SyMRI 12 is a magnetic resonance imaging system classified as Class IIa under the nomenclature code Z11050182. It is an active device that does not administer medicine and is not intended for measuring functions.

The device is not sterile, not implantable, and not reusable. It does not contain animal or human tissues, latex, or medicinal products. It is placed on the market under FDA 510(k) and MDR authorisations with basic UDI 73400247S01QP and primary DI 07340024700047.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number28620110677-01 Date8 Jun 2026IssuedStatusActive expires 30 Sep 2027
United StatesFDA 510(k) 510(k) NumberK203372 Date3 Nov 2021IssuedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · 510(k) · synced 22 Oct 2026

Device Name
SyMRI
Model / Reference
0004
Primary DI / UDI-DI
07340024700047
Basic UDI-DI
73400247S01QP
EMDN Code
Z11050182 Magnetic resonance (mr) systems - software accessories
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000003513

Other devices from SyntheticMR AB

  • SyMRI 15

    Class IIa

  • cNeuro cMRI

    Class IIa

Questions

  • Is the SyMRI 12 device sterile?

    The SyMRI 12 device is not sterile, as indicated by the STERILE field being set to 0 in the specifications.

  • Can the SyMRI 12 be reused after use?

    The SyMRI 12 is not reusable, as the REUSABLE field is 0, meaning it is intended for single use only.

  • What regulatory authorisations apply to the SyMRI 12?

    The SyMRI 12 is authorised under FDA 510(k) and MDR, as stated in the AUTHORIZATIONS field of the device data.

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (2)

  • EUDAMED a04ecdc3-a2f4-457a-b484-3be8145aaf71 85 fields · synced 22 Oct 2026
  • FDA 510(k) K181093 1 fields · synced 18 May 2026