Radrex-I, Sw V4.00 Model Drad-3000E

• • Terminated Z-1958-2019 FDA Class II ·initiated 16 Oct 2018

  software malfunction; It was found when a user performs radiography using the wireless flat panel detector (FPD), a message window displays on the monitor stating image transmission was not completed and there was no image available. It also showed the "OK" button to reacquire image data from the FPD, and the "Cancel" button to cancel the acquisition . When the user selects the "OK" button, the same message window appears. This prompted the user to repeat the same operation several times and finally select the "Cancel" button to quit the reacquistion mode.

• • Terminated Z-2964-2018 FDA Class II ·initiated 18 Apr 2018

  It was found when an operator performs a radiography using the wireless flat panel detector (FPD), a message window was displayed on the monitor stating image transmission was not completed and there was no image. It also showed the OK button to reacquire image data form the FPD, and the Cancel button to cancel the reacquisition. When the operator selects the OK button, the same message window appears. The operator then repeated the same operation several times and finally selected the Cancel button to quit the reacquisition mode.

• • Terminated Z-3111-2017 FDA Class II ·initiated 23 Mar 2017

  It was discovered during a procedure that when the operator made an exposure on the wireless x-ray detector and the image data was sent to the digital radiography system, and error message was displayed " System Error (2063)" which required a reboot and loss of the image.

510(k) Number

K122842 ↗

FDA Product Code

MQB

Device Class

Class II

Regulation

21 CFR Part 892.1680

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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