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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device x-ray controls - radiographic
Definition A device which controls input power to the x-ray high-voltage generator and/or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices which control the technique factors of an x-ray exposure for generating and recordingan x-ray pattern for the purpose of providing the user with an image(s) after termination of the exposure.
Product CodeRCB
Device Class Not Classified

MDR Year MDR Reports MDR Events
2019 25 25
2020 2 2
2021 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 30 30

Patient Problems MDRs with this Patient Problem Events in those MDRs
Radiation Exposure, Unintended 27 27

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