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Digital Pathology Display

FDA product code PZZ · 3 cleared devices

Class 2 Pathology
Regulation
21 CFR 864.3700
Review panel
PA
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2017-12-21 – 2025-05-23

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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