Digital Pathology Display

PZZ · Class II — Moderate Risk (510(k) clearance required) · Pathology · 21 CFR 864.3700

Classification

FDA Product Code: PZZ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 864.3700
Review panel: PA
Medical specialty: Pathology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 3
Registered establishments: 5

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown