Cleared Traditional

K181185 - Change Healthcare Enterprise Viewer

K181185 is the FDA 510(k) clearance for Change Healthcare Enterprise Viewer by Change Healthcare Canada Company. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K181185 · Change Healthcare Canada Company · Radiology device
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Aug 2018
Decision
118d
Days
Class 2
Risk

K181185 is an FDA 510(k) clearance for the Change Healthcare Enterprise Viewer. 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 Change Healthcare Canada Company (Richmond, CA). The FDA issued a Cleared decision on August 29, 2018 after a review of 118 days - within the typical 510(k) review window.

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 Change Healthcare Canada Company devices

Submission Details

510(k) Number K181185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2018
Decision Date August 29, 2018
Days to Decision 118 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
11d slower than avg
Panel avg: 107d · This submission: 118d
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 Consultant

Change Healthcare Technologies, LLC
Nadia Marchant

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.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 1092
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K181185.
syngo.via View&GO (Version VA10A)
K182208 · Siemens Healthcare GmbH · Sep 2018
Multi Modality Viewer
K182230 · Vital Images, Inc. · Sep 2018
AmCAD-UT Detection 2.2
K180006 · Amcad Biomed Corporation · Aug 2018
IGTFusion
K180522 · Igi Technologies · Aug 2018
ONIS-PACS
K181318 · Digitalcore Co., Ltd. · Aug 2018
CubeVue
K181962 · Curvebeam, LLC · Aug 2018