Home / 510(k) Clearances / K082341

510(k) K082341

DSA 2000EX by Eigen, LLC — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2008
Date Received
August 15, 2008
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 Eigen, LLC

  • K222222 — Artemis, Artemis TPO, Artemis MX (October 12, 2023)
  • K173744 — ProFuse CAD (November 21, 2018)
  • K162474 — Artemis (October 21, 2016)
  • K081093 — 3-D IMAGING WORKSTATION (May 1, 2008)
  • K063846 — EIGEN DSA 2000 (January 26, 2007)
  • K933115 — DIGITAL DISK RECORDER (April 7, 1994)
  • K924164 — DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPT (November 23, 1992)
  • K923585 — DIGITAL FLUORO STORE (October 21, 1992)
  • K913012 — DIGITAL FLUORO STORE(DFS) W/NUMERICAL SUFFIXES (September 23, 1991)
  • K905111 — DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES (January 25, 1991)

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)