FDA 510(k)

Enterprise Imaging XERO Viewer 8.1

K-Number: K170434 · 2017-07-03

Decision Date2017-07-03

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Enterprise Imaging XERO Viewer 8.1 is a medical device manufactured by Agfa Healthcare N.V.. It received FDA 510(k) clearance on 2017-07-03 under approval number K170434. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Enterprise Imaging XERO Viewer 8.1?

Enterprise Imaging XERO Viewer 8.1 is a medical device that received FDA 510(k) clearance on 2017-07-03. It is manufactured by Agfa Healthcare N.V.. The 510(k) number is K170434.

When was Enterprise Imaging XERO Viewer 8.1 approved by the FDA?

Enterprise Imaging XERO Viewer 8.1 received FDA 510(k) clearance on 2017-07-03, under approval number K170434.

What company makes Enterprise Imaging XERO Viewer 8.1?

Enterprise Imaging XERO Viewer 8.1 is manufactured by Agfa Healthcare N.V..

What is the FDA product code for Enterprise Imaging XERO Viewer 8.1?

The FDA product code for Enterprise Imaging XERO Viewer 8.1 is LLZ.

Other Devices by Agfa Healthcare N.V.

K161368DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) K161061IMPAX Volume Viewing 4.0 K172784DX-D Imaging Package K180589DR 800 with MUSICA Dynamic K252199AGFA HealthCare Enterprise Imaging

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.