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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 In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.1990
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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