Cleared Traditional

K170434 - Enterprise Imaging XERO Viewer 8.1

K170434 is an FDA 510(k) clearance for Enterprise Imaging XERO Viewer 8.1, manufactured by Agfa Healthcare N.V.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K170434 · Agfa Healthcare N.V. · Radiology device
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Jul 2017
Decision
140d
Days
Class 2
Risk

K170434 is an FDA 510(k) clearance for the Enterprise Imaging XERO Viewer 8.1. 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 Agfa Healthcare N.V. (Mortsel, BE). The FDA issued a Cleared decision on July 3, 2017 after a review of 140 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 Agfa Healthcare N.V. devices

FDA 510(k) Submission Details - K170434

510(k) Number K170434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2017
Decision Date July 03, 2017
Days to Decision 140 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
33d slower than avg
Panel avg: 107d · This submission: 140d
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

Agfa Healthcare Corporation
ShaeAnn Cavanagh

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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