CT 8000 Digital Injection System

• • Terminated Z-1828-2008 FDA Unclassified (pre-2012) ·initiated 14 Apr 2008

  The tubing metal begins to crack and thin. When this occurs it causes the tubing material to crack around the screws. This can cause the tubing to fall from the mounting plug.

510(k) Number

K912944 ↗

FDA Product Code

DXT

Device Class

Class II

Regulation

21 CFR Part 870.1650

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Angiomat 6000

  Class II

  FDA 510(k) K860204 Active Cleared 2 May 1986

• Automatic Cassette Loader

  Class II

  FDA 510(k) K902761 Active Cleared 9 Oct 1990

• X-Ray Film, Convey or System

  Class II

  FDA 510(k) K760279 Active Cleared 13 Aug 1976

• Hydrajust IV Urological Table

  Class II

  FDA 510(k) K920742 Active Cleared 27 Apr 1992

• Neuro Vision Radiographic X-Ray System

  Class II

  FDA 510(k) K904146 Active Cleared 13 Dec 1990

• L-F Coiled Extension Tubing

  Class II

  FDA 510(k) K882329 Active Cleared 2 Sep 1988

See all devices from Mallinckrodt Group, Inc. →