Heimann Systems Corporation

Company: Heimann Systems Corporation
Product: Cabinet x-ray system
Date: 10/30/2002

21 CFR 1020.40(c)(10) requires that x-ray systems designed for security screening of carried possessions in public facilities shall be provided with means to insure operator presence at the control area in a position which permits surveillance of the ports during generation of x-radiation. We observed that this system was installed in a public area of an office building and did not require the operator to be present to produce x-rays. The conveyor forward and backward buttons could be pressed once and the conveyor would continue to operate. This allowed x-ray generation to take place when an object was placed on the conveyor and passed through the system even with no one present.

FDA District: Center for Devices and Radiological Health (CDRH)

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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