Home / 510(k) Clearances / K042383

510(k) K042383

RSA-CMS by Medis Medical Imaging Systems BV — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2004
Date Received
September 1, 2004
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 Medis Medical Imaging Systems BV

  • K182611 — Qangio XA 3D (May 30, 2019)
  • K140587 — MR-CT VVA (January 6, 2015)
  • K112807 — X-RAY VVA (February 27, 2012)
  • K073156 — QPLAQUE MR (March 4, 2008)
  • K062386 — QANGIO CT (October 5, 2006)
  • K050703 — QBRAIN (April 21, 2005)
  • K041162 — ORTHO-CMS (July 27, 2004)
  • K040746 — MRA-CMS (June 8, 2004)
  • K033774 — CT-MASS (March 2, 2004)
  • K023970 — QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS (January 24, 2003)

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)