Home / 510(k) Clearances / K080515

510(k) K080515

FMRI HARDWARE SYSTEM by Nordicneurolab — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2008
Date Received
February 25, 2008
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

  • 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

  • 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)