Home / 510(k) Clearances / K113701

510(k) K113701

VISIA NEURO by Mevis Medical Solutions AG — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2012
Date Received
December 16, 2011
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 Mevis Medical Solutions AG

  • K232045 — MeVis Liver Suite (October 27, 2023)
  • K201501 — Veolity (February 23, 2021)
  • K120207 — VISIA (April 23, 2012)
  • K120484 — VISIA ONCOLOGY (March 27, 2012)
  • K113337 — VISIA DYNAMIC REVIEW (December 30, 2011)

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)