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Nordicbrainex Software Version 1.0

by Nordicimaginglab AS

510(k) K092102

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK092102 Date25 Aug 2009ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2045-2018 FDA Class II initiated 21 Dec 2012

    There is an error related to the relative geometry between fiber tracts in a fiber group and images. The error occurs in the following situations: A group of fibers has been selected using the VOI functionality and put into a fiber group. This is done with images series A visualized in the 3D viewer. Then a new images series B is visualized in the 3D viewer. If image series A and B have the same geometrical resolution (pixel sizes and slice distances), the coregistration matrix taking A to B will not be applied to the fiber group, and therefore the fiber group will in general not be positioned correctly on B in the 3D viewer. Furthermore, if the fiber group is exported as a new image series the fibers could be misplaced, and similarly if the fibers are visualized in the MPR on B, the positioning will not be correct. The misalignment will be equal to the rotations/translations necessary to align A with B.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

The device is a software product named Nordicbrainex Software, Version 1.0, developed by Nordicimaginglab AS. It is classified under the product code LLZ and has been determined to be substantially equivalent to a predicate device through a traditional 510(k) clearance process.

The software received FDA 510(k) clearance under K092102 on August 25, 2009, following submission on July 14, 2009. The review was conducted by the Radiology advisory committee (RA), and the device is manufactured at Mollendalsveien 65c, Bergen, Hordaland, Norway, with postal code 5009.

Other devices from Nordicimaginglab AS

Questions

AI-generated answers, 23 Sep 2026

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

  • What is Nordicbrainex Software Version 1.0 used for?

    Nordicbrainex Software Version 1.0 is a software product designed for use in radiology to support medical image analysis, as indicated by its product code LLZ and review by the Radiology advisory committee during its FDA 510(k) clearance process.

  • How was Nordicbrainex Software Version 1.0 cleared for market release?

    The software received FDA 510(k) clearance through a traditional submission process, demonstrating substantial equivalence to a predicate device, with clearance granted under K092102 on August 25, 2009, following review by the Radiology advisory committee.

  • Who manufactures Nordicbrainex Software Version 1.0 and where is it produced?

    Nordicbrainex Software Version 1.0 is manufactured by Nordicimaginglab AS at their facility located at Mollendalsveien 65c, Bergen, Hordaland, Norway, with postal code 5009.