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510(k) K191032

fMRI Hardware System by Nordicneurolab AS — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2019
Date Received
April 18, 2019
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)
  • 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)
  • K080515 — FMRI HARDWARE SYSTEM (May 16, 2008)

Other clearances for product code LNH

  • 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)
  • K253499 — Ascent3T Neonatal Magnetic Resonance Imaging System (January 26, 2026)
  • K252379 — AIR Recon DL (December 23, 2025)
  • K252838 — MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETO (December 19, 2025)