Cleared Traditional

ARiX RAD Radiographic System (K182134) - FDA 510(k) Clearance

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

K182134 · Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. · Radiology device
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Nov 2018
Decision
112d
Days
Class 2
Risk

K182134 is an FDA 510(k) clearance for the ARiX RAD Radiographic System. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. (El Marques, Queretaro, MX). The FDA issued a Cleared decision on November 26, 2018 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. devices

Submission Details

510(k) Number K182134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2018
Decision Date November 26, 2018
Days to Decision 112 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
5d slower than avg
Panel avg: 107d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 Consultant

Emergo Global Consulting, LLC
Stuart R. Goldman

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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