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Nordicice Software

by Nordicimaginglab AS

510(k) K082441

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK082441 Date21 Nov 2008ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2061-2018 FDA Class II initiated 3 Jul 2015

    The bug causes BOLD activation maps to be visualized as overlays without taking the coregistration into account. Any output created from these activation maps as overlays will not be adjusted according to the coregistration.

    • Terminated Z-2044-2018 FDA Class II initiated 12 Sep 2014

    An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior flipping of images.

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  • Withdrawn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

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