Skip to content

Functional MR V1.0

by Olea Medical S.A.S. France EUDAMED510(k)

Ref MOD030

EMDN Z11050182

Regulatory status

as of 24 Oct 2026

Recall ongoing on a related submission. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++EOLEFUNCTIONALMRDS Basic UDI-DIDate29 Apr 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK221426 Date6 Jul 2022IssuedStatusActive

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
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Certificates: none listed in EUDAMED

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0122-2024 FDA Class II initiated 10 Aug 2023 via K221426, on the same 510(k)

    When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting multiple volumes of interest, a functional magnetic resonance software bug may cause file contents and associated series descriptions to not match, which could lead to a misinterpretation of clinical data.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

EUDAMED · 510(k) · synced 24 Oct 2026

Model / Reference
MOD030
Primary DI / UDI-DI
+EOLEFUNCTIONALMRV1P00
Basic UDI-DI
++EOLEFUNCTIONALMRDS
EMDN Code
Z11050182 Magnetic resonance (mr) systems - software accessories
Device Class
Class IIa
Special Device Type
Software
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000002403

Other devices from Olea Medical S.A.S.

See all devices from Olea Medical S.A.S. →

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 04d7d8f1-23ab-4bf3-83e4-b3d90db23e2b 61 fields · synced 24 Oct 2026
  • FDA 510(k) K221426 1 fields · synced 18 May 2026