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U.S. Department of Health and Human Services

Product Classification

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Device full field digital, system, x-ray, mammographic
Regulation Description Full-field digital mammography system.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeMUE
Premarket Review Office of Radiological Health (OHT8)
Radiological Imaging and Radiation Therapy Devices (DHT8C)
Submission Type 510(k)
Regulation Number 892.1715
Device Class 2
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
Guidance Documents
Third Party Review
Accredited Persons
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