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FDA 510(k)

DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)

K-Number: K161368 · 2016-09-22

ApplicantAgfa Healthcare N.V.
Decision Date2016-09-22
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) is a medical device manufactured by Agfa Healthcare N.V.. It received FDA 510(k) clearance on 2016-09-22 under approval number K161368. 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 (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)?

DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) is a medical device that received FDA 510(k) clearance on 2016-09-22. It is manufactured by Agfa Healthcare N.V.. The 510(k) number is K161368.

When was DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) approved by the FDA?

DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) received FDA 510(k) clearance on 2016-09-22, under approval number K161368.

What company makes DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)?

DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) is manufactured by Agfa Healthcare N.V..

What is the FDA product code for DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)?

The FDA product code for DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) is MQB.

Other Devices by Agfa Healthcare N.V.

K161061IMPAX Volume Viewing 4.0 K172784DX-D Imaging Package K170434Enterprise Imaging XERO Viewer 8.1 K180589DR 800 with MUSICA Dynamic K252199AGFA HealthCare Enterprise Imaging

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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.

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