Software Algorithm Device To Assist Users In Digital Pathology

QPN · Class II — Moderate Risk (510(k) clearance required) · Pathology · 21 CFR 864.3750

Classification

FDA Product Code: QPN
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 864.3750
Review panel: PA
Medical specialty: Pathology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A software algorithm device to assist users in digital pathology is an in vitro diagnostic device intended to evaluate acquired scanned pathology whole slide images. The device uses software algorithms to provide information to the user about presence, location, and characteristics of areas of the image with clinical implications. Information from this device is intended to assist the user in determining a pathology diagnosis.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 2

Source

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