Not Cleared Direct

DEN170073 - ContaCT

DEN170073 is an FDA 510(k) submission for ContaCT, manufactured by Viz.Al, Inc.. The device is a Class 2 Radiology device with product code QAS cleared through the Direct 510(k) pathway after a 137-day FDA review.

DEN170073 · Viz.Al, Inc. · Radiology device
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Feb 2018
Decision
137d
Days
Class 2
Risk

DEN170073 is an FDA 510(k) submission (not cleared) for the ContaCT. Classified as Radiological Computer-assisted Triage And Notification Software (product code QAS), Class II - Special Controls.

Submitted by Viz.Al, Inc. (San Francisco, US). The FDA issued a Not Cleared (DENG) decision on February 13, 2018 after a review of 137 days.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2080 - 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: Incremental AI imaging tool. 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.

FDA 510(k) Submission Details - DEN170073

510(k) Number DEN170073 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 29, 2017
Decision Date February 13, 2018
Days to Decision 137 days
Submission Type Direct
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 107d · This submission: 137d
Pathway characteristics

QAS Device Classification - Class 2, Special Controls

Product Code QAS Radiological Computer-assisted Triage And Notification Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2080
Definition Radiological Computer-assisted Triage And Notification Software Is An Image Processing Device Intended To Aid In Prioritization And Triage Of Time Sensitive Patient Detection And Diagnosis Based On The Analysis Of Medical Images Acquired From Radiological Signal Acquisition Systems. The Device Identifies Or Prioritizes Time Sensitive Imaging For Review By Prespecified Clinical Users Based On Software-based Image Analysis But Does Not Provide Information From The Image Analysis Other Than Triage And Notification .
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.

DEN170073 · ContaCT
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