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510(k) K241608

nordicMEDiVA by Nordicneurolab AS — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2024
Date Received
June 4, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

Other clearances by Nordicneurolab AS

  • K243209 — nordicMEDiVA (October 22, 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)
  • K080515 — FMRI HARDWARE SYSTEM (May 16, 2008)

Other clearances for product code LLZ

  • K260479 — TheraSphere 360™ Y-90 Management Platform (March 13, 2026)
  • K253111 — Aeka Imaging (March 13, 2026)
  • K251964 — Mimics Thoracic Planner (March 12, 2026)
  • K253551 — VELYS™ Hip Navigation (March 6, 2026)
  • K253486 — SKIA-Head (Model: SKIA-ST00) (February 23, 2026)
  • K260205 — AS Software Version Asera (February 19, 2026)
  • K253927 — LiveMedica Enterprise PACS (February 6, 2026)
  • K251577 — LAIA XR (February 6, 2026)
  • K253639 — View (January 8, 2026)
  • K253784 — 3DICOM MD Cloud (January 8, 2026)