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U.S. Department of Health and Human Services

Product Classification

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Device system, image processing, radiological
Regulation Description Picture archiving and communications system.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeLLZ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.2050
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Documents
  • Guidance for the Submission of Premarket Notifications for Medical Image Management Devices
  • Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm107549.htm] 
Third Party Review
Accredited Persons

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