Cleared Traditional

K161518 - PACS CORE/ENCORE

K161518 is an FDA 510(k) clearance for PACS CORE/ENCORE, manufactured by Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K161518 · Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. · Radiology device
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Aug 2016
Decision
76d
Days
Class 2
Risk

K161518 is an FDA 510(k) clearance for the PACS CORE/ENCORE. 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. (El Marques Queretaro, MX). The FDA issued a Cleared decision on August 17, 2016 after a review of 76 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

FDA 510(k) Submission Details - K161518

510(k) Number K161518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2016
Decision Date August 17, 2016
Days to Decision 76 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
31d faster than avg
Panel avg: 107d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

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 Consultant

O Tech, Inc.
Carl Alletto

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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