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U.S. Department of Health and Human Services

Product Classification

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Device digitizer, image, radiological
Regulation Description Medical image digitizer.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeLMA
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type Enforcement Discretion
Regulation Number 892.2030
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for the Submission of Premarket Notifications for Medical Image Management Devices
Third Party Review
Accredited Persons

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