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OptimMRI v1.2.0

by Rebrain, Sas

OptimMRI v1.2.0 is a Class II device made by Rebrain, Sas, cleared under FDA 510(k) K230150 on 21 Jul 2023 and listed in FDA GUDID since 8 Dec 2023 (UDI-DI 03770021895011), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K230150

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03770021895011 UDI-DI Date8 Dec 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK230150 Date21 Jul 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K230150 decided 21 Jul 2023 Active
  • FDA GUDID UDI-DI 03770021895011 listed 8 Dec 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K230150
  2. Listed FDA GUDID 03770021895011

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
OptimMRI
Generic name
Stereotactic system application software
Model / reference
v1.2.0
Primary DI / UDI-DI
03770021895011
510(k) Number
FDA product code
QIH, LLZ
GMDN term
Stereotactic system application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Stereotactic system application software

Other devices from Rebrain, Sas

  • OptimMRI

    Class II

  • OptimMRI (v2)

    Class II

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)