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OptimMRI (v2)

by Rebrain, Sas

510(k) K242054

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K242054↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK242054 Date12 Aug 2024ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K242054 decided 12 Aug 2024 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
QIH
Device class
Class II
Regulation
21 CFR Part 892.2050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

OptimMRI (v2) is an AI-enabled Automated Radiological Image Processing Software designed for automated analysis of MRI scans. It leverages machine learning to identify and delineate regions of interest within brain imaging, supporting precise preoperative planning and surgical targeting.

This device is supplied as Software as a Medical Device (SaMD) and is intended for use in radiology workflows, requiring MRI-compatible hardware for image acquisition. It is classified as Class II under Special Controls and has received FDA 510(k) clearance (K242054) and MDR authorization. The device is non-sterile, reusable, and operates within the QIH product code category for automated radiological processing systems.

Devices cleared under K242054

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K242054
UDI-DISize and differences
OptimMRI (v2) v2.0.1
Rebrain, Sas
v2.0.103770021895035 —On the market

Similar devices

Other devices filed under FDA product code QIH (Automated Radiological Image Processing Software).

Other devices from Rebrain, Sas

  • OptimMRI v1.2.0

    Class II

  • OptimMRI

    Class II