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U.S. Department of Health and Human Services

Product Classification

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Device cross-sectional mammographic xray system
Definition Diagnostic breast imaging. Imaging of the breast by cross-sectional x-ray imaging for diagnostic purposes.
Physical State medical diagnostic x-ray imaging system
Technical Method x-ray imaging
Target Area breast
Review Panel Radiology
Product CodeOLQ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible