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U.S. Department of Health and Human Services

Product Classification

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Device system, image management, ophthalmic
Regulation Medical Specialty Radiology
Review Panel Ophthalmic
Product CodeNFJ
Premarket Review Ophthalmic Devices (DHT1A)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 892.2050
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review
Accredited Persons
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