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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
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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