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supply digital FDA approved x ray unit

On february 8, 2011, fda approved an alternative standard regarding the time period allowed for corrective action to be taken for the carestream directview cr
Apr 01, 2019 · x-ray control means 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.
A mammographic unit is at the time of the inspection, a mammographic unit is found to not meet one or more of the specific equipment requirements listed in 21 cfr 900.12(b) (3-10). must the unit immediately be taken out of service?

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