Product code PZZ

Device name

Digital Pathology Display

Medical specialty

Pathology

Device class

2

Regulation number

864.3700

Review panel

PA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset