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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 and diagnosis.
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
Premarket Review Office of Radiological Health (OHT8)
Division of Radiological Imaging and Radiation Therapy Devices (DHT8C)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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