Home / 510(k) Clearances / K903821

510(k) K903821

PSC-1 W/OTHER NUMERICAL by Eigen — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1990
Date Received
August 20, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Other clearances by Eigen

  • K222222 — Artemis, Artemis TPO, Artemis MX (October 12, 2023)
  • K173744 — ProFuse CAD (November 21, 2018)
  • K162474 — Artemis (October 21, 2016)
  • K082341 — DSA 2000EX (August 29, 2008)
  • 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)

Other clearances for product code JAA

  • K251650 — Insight Enhanced™ DRF (EN-1002-01) (September 16, 2025)
  • K242488 — Soteria E-View (January 6, 2025)
  • K242948 — Adora DRFi (04550010) (December 23, 2024)
  • K233380 — TRIDENT Mobile Fluoroscopy System (June 26, 2024)
  • K233945 — ProxiDiagnost N90 / Precision CRF (706110, 706400) (January 11, 2024)
  • K232910 — CombiDiagnost R90 (October 19, 2023)
  • K232526 — XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 (September 12, 2023)
  • K220871 — Nautilus (April 18, 2022)
  • K212890 — Nyquist.IQ (December 13, 2021)
  • K212837 — ProxiDiagnost N90 (September 21, 2021)