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U.S. Department of Health and Human Services

Product Classification
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Device automated breast ultrasound
Definition Adjunct to mammography for breast cancer screening.
Physical State May include different transducers
Technical Method Uses an automatic method of acquiring ultrasound images of the breast
Target Area Breast
Review Panel Radiology
Product CodePAA
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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