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U.S. Department of Health and Human Services

Product Classification

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Device full field digital,system,x-ray,mammographic
Regulation Description Full-field digital mammography system.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeMUE
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.1715
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full Field Digital Mammography System [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm107552.htm] 
Third Party Review Not Third Party Eligible
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