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U.S. Department of Health and Human Services

Product Classification
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Device imager, breast, electrical impedance
Review Panel Radiology
Product CodeNCL
Premarket Review Office of Radiological Health (OHT8)
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
Third Party Review Not Third Party Eligible
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