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OptimMRI

by Rebrain, Sas

510(k) K230150Ref v2

Active European Union and United States. Also listed in GUDID (US).

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

+1 more

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3770021895OMRI14M Basic UDI-DI 03770021895035UDI-DIDate8 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number03770021895035 UDI-DI Date22 Oct 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK242054 Date12 Aug 2024DecidedStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK230150 Date21 Jul 2023ClearedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 3770021895OMRI14M registered 8 Jul 2025 Active
  • FDA 510(k) K242054 decided 12 Aug 2024 Active· +1 more in the status table
  • FDA GUDID UDI-DI 03770021895035 listed 22 Oct 2024 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K230150
  2. Cleared FDA 510(k) K242054
  3. Listed FDA GUDID 03770021895035
  4. Registered EUDAMED 3770021895OMRI14M

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  • Withdrawn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) · GUDID

Trade name
OptimMRI EUDAMED
OptimMRI (v2) GUDID
Generic name
Stereotactic system application software
Model / reference
v2 EUDAMED
v2.0.1 GUDID
Primary DI / UDI-DI
03770021895035
Basic UDI-DI
3770021895OMRI14M
510(k) Number
FDA product code
QIH, LLZ
EMDN code
Z12100692 Stereotactic neurosurgery instruments - medical device software
GMDN term
Stereotactic system application software
Device class
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 892.2050
Special device type
Software
EU registration type
Standard device
EU market of registration
Spain
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 3 fields differ

FieldEUDAMED510(k)GUDID
Model / referenceEUDAMED
v2
510(k)
—
GUDID
v2.0.1
510(k) NumberEUDAMED
—
510(k)
K230150
GUDID
K242054
Device classEUDAMED
Class IIa
510(k)
Class II
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

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

Cited by

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 is a magnetic resonance imaging (MRI) optimization device designed to enhance MRI scan quality and efficiency. It is classified under the product code QIH and falls within the Radiology advisory committee category, supporting diagnostic imaging workflows by refining signal processing and artifact reduction.

The device is supplied as a software-based solution, intended for use in MRI-compatible environments. It is intended for single-use or reusable configurations depending on the implementation, though no explicit sterility or reuse instructions are provided in the data. Authorized under FDA 510K clearance and MDR compliance, it operates within standard MRI safety guidelines without requiring special storage conditions.

Devices cleared under K230150

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 K230150
UDI-DISize and differences
OptimMRI v1.2.0
Rebrain, Sas
v1.2.003770021895011 —On the market

Similar devices in this category

Other devices filed under STEREOTACTIC NEUROSURGERY INSTRUMENTS.

Other devices from Rebrain, Sas

  • OptimMRI v1.2.0

    Class II

  • OptimMRI (v2)

    Class II

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)