Cleared Traditional

K251417 - ReVISION 2

K251417 is an FDA 510(k) clearance for ReVISION 2, manufactured by Argus Cognitive, Inc.. The device is a Class 2 Radiology device with product code QIH cleared through the Traditional 510(k) pathway after a 490-day FDA review.

K251417 · Argus Cognitive, Inc. · Radiology device
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Sep 2026
Decision
490d
Days
Class 2
Risk

K251417 is an FDA 510(k) clearance for the ReVISION 2. Classified as Automated Radiological Image Processing Software within the QIH classification (a category dominated by AI-based automated radiology processing systems), Class II - Special Controls.

Submitted by Argus Cognitive, Inc. (Hanover, US). The FDA issued a Cleared decision on September 9, 2026 after a review of 490 days - an unusually long review period, suggesting complex equivalence evaluation.

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

FDA 510(k) Submission Details - K251417

510(k) Number K251417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2025
Decision Date September 09, 2026
Days to Decision 490 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
383d slower than avg
Panel avg: 107d · This submission: 490d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QIH Device Classification - Class 2, Special Controls

Product Code QIH Automated Radiological Image Processing Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code.
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.

Regulatory Peers - QIH Automated Radiological Image Processing Software

All 329
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