Cleared Traditional

K160458 - BI IMAGE-X EVOLUTION

K160458 is an FDA 510(k) clearance for BI IMAGE-X EVOLUTION, manufactured by Radiotecnologia Industrial S.A. DE C.V.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K160458 · Radiotecnologia Industrial S.A. DE C.V. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
122d
Days
Class 2
Risk

K160458 is an FDA 510(k) clearance for the BI IMAGE-X EVOLUTION. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Radiotecnologia Industrial S.A. DE C.V. (Ixtapaluca, MX). The FDA issued a Cleared decision on June 20, 2016 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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.

FDA 510(k) Submission Details - K160458

510(k) Number K160458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2016
Decision Date June 20, 2016
Days to Decision 122 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
15d slower than avg
Panel avg: 107d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EHD Device Classification - Class 2, Special Controls

Product Code EHD Unit, X-ray, Extraoral With Timer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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

Denterprise International, Inc. / 510k FDA Consulting
Claude Berthoin

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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