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U.S. Department of Health and Human Services

Product Classification
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Device transilluminator (diaphanoscope)
Regulation Description Transilluminator for breast evaluation.
Definition Classified August 17, 1995: 60 fr 36639: Classification into Class III for the transilluminator (diaphanoscope or lightscanner) for breast evaluation requires manufacturers of transilluminators to submit safety and effectiveness tests for the device.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeLEK
Premarket Review Office of Radiological Health (OHT8)
Radiological Imaging and Radiation Therapy Devices (DHT8C)
Submission Type PMA
Regulation Number 892.1990
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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