Scenaria Whole-Body X-Ray CT System

• • Terminated Z-0271-2020 FDA Class II ·initiated 16 Oct 2019

  There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system.

• • Terminated Z-2392-2016 FDA Class II ·initiated 30 Jun 2015

  The firm discovered that the centrifugal force applied to the power supply may cause it to fail over time. The exam performed at the time of the failure will likely be lost, resulting in the need to rescan the patient.

• • Terminated Z-2037-2012 FDA Class II ·initiated 4 May 2012

  Hitachi discovered a software error in the Reconstruction Status function that creates a potential risk that a patient study will not be fully reconstructed. When multiple reconstructions are queued for processing, if a queue is suspended and the task order changed, the second queue may not reconstruct the full range of slices. This may result in missing diagnostic data.

510(k) Number

K101888 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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