Diagnostic ultrasound reporting guide (21 CFR 1002.10)

Diagnostic ultrasound reporting guide (21 CFR 1002.10)

by United States. Bureau of Radiological Health. Division of Compliance

Part of HHS publication -- (FDA) 81-8145

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"This guide is to be used by manufacturers of medical diagnostic ultrasound equipment in the preparation of initial and model change reports to be filed with the Bureau of Radiological Health, as required by 21 CFR 1002.10 and 1002.12, issued under authority of the Radiation Control for Health and Safety Act of 1968"--Introduction.

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