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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 Medical Specialty Radiology
Review Panel Radiology
Product CodeMUE
Premarket Review Division of Radiological Health (DRH)
Division of Radiological Health (DRH)
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
Third Party Review
Accredited Persons
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