Medrad Stellant CT Injector System with P3T Cardiac

• • Terminated Z-2768-2016 FDA Class II ·initiated 2 Aug 2016

  CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exhibit thermal events, such as: smoke and sparks of fire.

• • Terminated Z-1686-2015 FDA Class II ·initiated 20 Sep 2013

  The root cause investigation showed that the under-volume hazard can occur when the unit has been configured to prime with contrast, but instead primes with saline due to the configuration data not being sent to the injector head. This may create a non-optimal priming condition that could lead to under-infusion.

510(k) Number

K082905 ↗

FDA Product Code

DXT

Device Class

Class II

Regulation

21 CFR Part 870.1650

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Medrad, Inc. →