SCENARIA Phase 3 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-2839-2018 FDA Class II ·initiated 29 Jun 2018

  The firm received a complaint where, during patient positioning, the technologist was adjusting the patient table height and the table failed to stop when the control was released and contacted the CT gantry. The problem could not be duplicated at the site, so to avoid further issues while a root cause investigation was pursued, Hitachi choose to add an optional touch sensor to the gantry to add a redundant level of protection. It is conceivable that a patient s extremity may be caught between the tabletop and the gantry surface during uncontrolled motion or that the table contact of the gantry might cause internal damage to the unit.

510(k) Number

K150595 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Sirius Starmobile tiara

  Class II

  FDA 510(k) K143537 Active Cleared 6 Mar 2015

• Airis, Airis II

  Class II

  FDA 510(k) K992650 Active Cleared 8 Oct 1999

• Magnetic Resonance Diagnostic Device, Model Mrp-5000

  Class II

  FDA 510(k) K984272 Active Cleared 11 Dec 1998

• Eclos Computed Tomography X-Ray System

  Class II

  FDA 510(k) K071806 Active Cleared 28 Aug 2007

• ECG Monitor Model Ds-3130/3140

  Class II

  FDA 510(k) K961174 Active Cleared 21 Jun 1996

• SUPRIA w/guideShot Option

  Class II

  FDA 510(k) K161748 Active Cleared 17 Aug 2016

See all devices from Hitachi Medical Systems America, Inc. →