Cleared Abbreviated

K020658 - VIATRONIX V3D COLON (FDA 510(k) Clearance)

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

K020658 · Viatronix, Inc. · Radiology device
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Mar 2002
Decision
6d
Days
Class 2
Risk

K020658 is an FDA 510(k) clearance for the VIATRONIX V3D COLON. 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 Viatronix, Inc. (Stony Brook, US). The FDA issued a Cleared decision on March 7, 2002 after a review of 6 days - a notably fast clearance 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Incremental AI imaging tool. Standards-verified equivalence. 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 Viatronix, Inc. devices

Submission Details

510(k) Number K020658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2002
Decision Date March 07, 2002
Days to Decision 6 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 107d · This submission: 6d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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.

Regulatory Peers - LLZ System, Image Processing, Radiological

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