Cleared Traditional

Argus Cognitive ReVISION Software (K223322) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223322 · Argus Cognitive, Inc. · Radiology device
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Jul 2023
Decision
266d
Days
Class 2
Risk

K223322 is an FDA 510(k) clearance for the Argus Cognitive ReVISION Software. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Argus Cognitive, Inc. (Lebanon, US). The FDA issued a Cleared decision on July 24, 2023 after a review of 266 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate-to-high equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Argus Cognitive, Inc. devices

Submission Details

510(k) Number K223322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2022
Decision Date July 24, 2023
Days to Decision 266 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
159d slower than avg
Panel avg: 107d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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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