Not Cleared Direct

DEN170022 - QuantX (FDA 510(k) Clearance)

Class II Radiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN170022 · Quantitative Insights, Inc. · Radiology device
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Jul 2017
Decision
103d
Days
Class 2
Risk

DEN170022 is an FDA 510(k) submission (not cleared) for the QuantX. Classified as Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer (product code POK), Class II - Special Controls.

Submitted by Quantitative Insights, Inc. (Chicago, US). The FDA issued a Not Cleared (DENG) decision on July 19, 2017 after a review of 103 days.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2060 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Radiology review framework.

View all Quantitative Insights, Inc. devices

Submission Details

510(k) Number DEN170022 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 07, 2017
Decision Date July 19, 2017
Days to Decision 103 days
Submission Type Direct
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 107d · This submission: 103d
Pathway characteristics

Device Classification

Product Code POK Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2060
Definition Assist Users In Characterizing Lesions Identified On Acquired Medical Images
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

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