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510(k) K123306

NORDIC TUMOREX by Nordicneurolab — Product Code LLZ

K123306 is an FDA 510(k) premarket notification submitted by Nordicneurolab for the device "NORDIC TUMOREX". The FDA issued a decision of Substantially Equivalent on May 20, 2013. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Nordicneurolab has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2013
Date Received
October 24, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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

  • K251937 — nordicAudio (1.0) (March 20, 2026)
  • 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)
  • K092253 — MODIFICATION TO FMRI HARDWARE SYSTEM (October 8, 2009)

Other clearances for product code LLZ

  • K262120 — Avara Viewer (July 10, 2026)
  • K253899 — 3D-Anywhere (July 9, 2026)
  • K261465 — INDIRA CLOUD VIEWER (July 6, 2026)
  • K260576 — MeVis AVM Contour (June 30, 2026)
  • K260231 — MiPACS V5 (1.0.0) (June 25, 2026)
  • K253421 — Perfusion Measurement Platform v1 (June 22, 2026)
  • K261352 — 2D Hip Planning Software (June 8, 2026)
  • K260116 — CustoMED Viewer (June 3, 2026)
  • K254265 — Helion Viewer Suite (May 27, 2026)
  • K253831 — CMN Capillary Function with Virtual Expert for MRI, CT and CBCT (May 18, 2026)

FDA data resources