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U.S. Department of Health and Human Services

Product Classification

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Device camera, multi format, radiological
Regulation Description Medical image hardcopy device.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeLMC
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type Enforcement Discretion
Regulation Number 892.2040
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
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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