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U.S. Department of Health and Human Services

Product Classification

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Device display, diagnostic radiology
Regulation Description Picture archiving and communications system.
Definition The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.
Physical State Hardware and embedded software
Technical Method Hardware and embedded sofware for displaying radiological images.
Target Area Whole body
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodePGY
Premarket Review Division of Radiological Health (DRH)
Division of Radiological Health (DRH)
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons