FDA 510(k)

DX-D Imaging Package

K-Number: K172784 · 2017-10-13

Decision Date2017-10-13

Product CodeMQB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DX-D Imaging Package is a medical device manufactured by Agfa Healthcare N.V.. It received FDA 510(k) clearance on 2017-10-13 under approval number K172784. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DX-D Imaging Package?

DX-D Imaging Package is a medical device that received FDA 510(k) clearance on 2017-10-13. It is manufactured by Agfa Healthcare N.V.. The 510(k) number is K172784.

When was DX-D Imaging Package approved by the FDA?

DX-D Imaging Package received FDA 510(k) clearance on 2017-10-13, under approval number K172784.

What company makes DX-D Imaging Package?

DX-D Imaging Package is manufactured by Agfa Healthcare N.V..

What is the FDA product code for DX-D Imaging Package?

The FDA product code for DX-D Imaging Package is MQB.

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 K170434Enterprise Imaging XERO Viewer 8.1 K180589DR 800 with MUSICA Dynamic K252199AGFA HealthCare Enterprise Imaging

Related Devices (Code: MQB)

K162555EVS 4343, EVS 4343GDRTECH Corporation K162344INNOLUX RICInnolux Corporation K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai) , Ltd. K162552EVS 3643, EVS 3643GDRTECH Corporation K163019CareView 750Cw/750C X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd. K160143ClearVision ExamVue Flat Panel DetectorJpi Healthcare, Inc.

Official Source

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