De Novo · Radiology

ContaCT

by Viz.Al, Inc.

ContaCT is an AI-enabled medical device from Viz.Al, Inc. that the U.S. FDA granted through De Novo DEN170073 on February 13, 2018. Its lead review panel is Radiology and its primary product code is QAS (Radiological Computer-Assisted Triage And Notification Software).

See also FDA-cleared AI radiology devices in 2018, all FDA AI clearances in 2018, top radiology AI devices.

Key facts

Submission numberDEN170073
PathwayDe Novo
Date of final decision
Company (FDA list)Viz.Al, Inc.
Lead review panelRadiology
Primary product codeQAS — Radiological Computer-Assisted Triage And Notification Software
Applicant (openFDA)Viz.Al, Inc.
Applicant locationSan Francisco, CA, US
Device classClass 2
Regulation number21 CFR 892.2080
Decision codeDENG
Submission typeDirect

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

De Novo is the pathway for novel low-to-moderate-risk devices with no predicate. A granted De Novo creates a new device classification that later devices can use as a predicate. ContaCT went through this pathway (DEN170073).

openFDA lists it as a Class 2 device under 21 CFR 892.2080. Class II devices are moderate risk and are subject to general and special controls.

Product code QAS covers 86 devices on the FDA AI list. By decision date, this device is #1 of 86 under that code. Viz.Al, Inc. has 1 AI-enabled device on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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