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U.S. Department of Health and Human Services

Product Classification

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Device digital pathology display
Regulation Description Whole slide imaging system.
Definition The digital pathology display device is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from FDA-cleared whole-slide imaging scanners that are used for review and interpretation by trained pathologists.
Physical State Hardware and embedded software
Technical Method Hardware and embedded software for displaying digital pathology images of tissue on glass slides.
Target Area Histopathology slides of human clinical tissue specimens
Regulation Medical Specialty Pathology
Review Panel Pathology
Product CodePZZ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.3700
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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