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U.S. Department of Health and Human Services

Product Classification

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Device system, image management, ophthalmic
Regulation Description Picture archiving and communications system.
Regulation Medical Specialty Radiology
Review Panel Ophthalmic
Product CodeNFJ
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Intraocular and Corneal Implants Devices Branch (ICIB)
Submission Type 510(k)
Regulation Number 892.2050
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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