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nordicDSC 1.1

by Nordicneurolab AS

nordicDSC 1.1, a MRI system application software (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Nordicneurolab AS, was cleared under FDA 510(k) K212720 on 3 Mar 2022 and listed in FDA GUDID on 13 Sep 2022 (UDI-DI 07090042059046); the registry lists it as not in commercial distribution (GUDID) as of 12 Nov 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 12 Nov 2026

Documents

510(k) K212720

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07090042059046 UDI-DI Date13 Sep 2022ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK212720 Date3 Mar 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K212720 decided 3 Mar 2022 Active
  • FDA GUDID UDI-DI 07090042059046 listed 13 Sep 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K212720
  2. Listed FDA GUDID 07090042059046

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
nordicDSC
Generic name
MRI system application software
Model / reference
1.1
Primary DI / UDI-DI
07090042059046
510(k) Number
FDA product code
LLZ
GMDN term
MRI system application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

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Properties

Other properties (15, all answered No)