Digital Pathology Image Viewing And Management Software

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

Classification

FDA Product Code: QKQ
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: N

Definition

Digital pathology image viewing and management software device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.

Market data

Cleared 510(k) submissions: 13
Registered establishments: 12

Source

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