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U.S. Department of Health and Human Services

Product Classification
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Device optoacoustic imaging system
Definition The device is indicated for imaging the breast using optoacoustic technology for breast cancer diagnosis
Physical State Hardware and software for acquiring, processing, and displaying optoacoustic images.
Technical Method Images are acquired utilizing acoustic emissions caused by optical, pulsed excitation for visualization of the relative amount of laser light absorption by the tissue, depicting tissue oxygenation.
Target Area Breast
Review Panel Radiology
Product CodeQNK
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		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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