Home / 510(k) Clearances / K251937

510(k) K251937

nordicAudio (1.0) by Nordicneurolab AS — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2026
Date Received
June 24, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nuclear Magnetic Resonance Imaging
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

Other clearances by Nordicneurolab AS

  • K243209 — nordicMEDiVA (October 22, 2024)
  • K241608 — nordicMEDiVA (June 28, 2024)
  • K232680 — fMRI Hardware System (December 13, 2023)
  • K212720 — nordicDSC (March 3, 2022)
  • K191032 — fMRI Hardware System (November 27, 2019)
  • K163324 — nordicBrainEx (January 27, 2017)
  • K140956 — LCD MONITOR (August 7, 2014)
  • K133910 — NORDICBRAINEX (April 4, 2014)
  • K123306 — NORDIC TUMOREX (May 20, 2013)
  • K092253 — MODIFICATION TO FMRI HARDWARE SYSTEM (October 8, 2009)

Other clearances for product code LNH

  • K253862 — APERTO Lucent MRI System (April 6, 2026)
  • K253625 — Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing (March 27, 2026)
  • K260746 — S-scan Open (100001800) (March 27, 2026)
  • K254277 — Embrace Neonatal MRI System (March 13, 2026)
  • K253413 — LiverMultiScan (v6.0) (March 9, 2026)
  • K251901 — Magnifico Open (100009900) (March 5, 2026)
  • K253648 — Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/Q (February 23, 2026)
  • K260265 — MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (February 23, 2026)
  • K253780 — SIGNA™ Bolt (February 6, 2026)
  • K253779 — SIGNA™ Sprint Select (February 5, 2026)