Home / 510(k) Clearances / K950631

510(k) K950631

ID400 SERIES ARMBOARDS by Image Diagnostics, Inc. — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1995
Date Received
February 13, 1995
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 Image Diagnostics, Inc.

  • K944772 — MULTIPLE ED1600 SERIES RADIATION SHIELDS (October 20, 1994)
  • K942190 — ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE (August 17, 1994)

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)