De Novo · Radiology

QuantX

by Quantitative Insights, Inc

QuantX is an AI-enabled medical device from Quantitative Insights, Inc that the U.S. FDA granted through De Novo DEN170022 on July 19, 2017. Its lead review panel is Radiology and its primary product code is POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer).

See also FDA-cleared AI radiology devices in 2017, all FDA AI clearances in 2017, top radiology AI devices.

Key facts

Submission numberDEN170022
PathwayDe Novo
Date of final decision
Company (FDA list)Quantitative Insights, Inc
Lead review panelRadiology
Primary product codePOK — Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Applicant (openFDA)Quantitative Insights, Inc.
Applicant locationChicago, IL, US
Device classClass 2
Regulation number21 CFR 892.2060
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. QuantX went through this pathway (DEN170022).

openFDA lists it as a Class 2 device under 21 CFR 892.2060. Class II devices are moderate risk and are subject to general and special controls.

Product code POK covers 22 devices on the FDA AI list. By decision date, this device is #1 of 22 under that code. Quantitative Insights, 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.

Similar devices (product code POK)