FDA product code PZZ

Digital Pathology Display

Pathology·Class 2·21 CFR 864.3700
US regulatory classifications
US Product Code (FDA)
PZZ
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 864.3700
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Medical specialty
Pathology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
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.

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About this record

Digital Pathology Display is a medical device type in the Pathology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.