Cleared Traditional

K123650 - ARIX RAD ACQUISITION CONSOLE

K123650 is the FDA 510(k) clearance for ARIX RAD ACQUISITION CONSOLE by Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K123650 · Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. · Radiology device
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Feb 2013
Decision
85d
Days
Class 2
Risk

K123650 is an FDA 510(k) clearance for the ARIX RAD ACQUISITION CONSOLE. 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 Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. (Denton, US). The FDA issued a Cleared decision on February 20, 2013 after a review of 85 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 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 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 Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. devices

Submission Details

510(k) Number K123650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2012
Decision Date February 20, 2013
Days to Decision 85 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 107d · This submission: 85d
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.

Regulatory Peers - LLZ System, Image Processing, Radiological

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