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FDA 510(k)

DX-D Imaging Package with XD Detectors

K-Number: K211790 · 2021-07-30

ApplicantAgfa N.V.
Decision Date2021-07-30
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DX-D Imaging Package with XD Detectors is a medical device manufactured by Agfa N.V.. It received FDA 510(k) clearance on 2021-07-30 under approval number K211790. 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 with XD Detectors?

DX-D Imaging Package with XD Detectors is a medical device that received FDA 510(k) clearance on 2021-07-30. It is manufactured by Agfa N.V.. The 510(k) number is K211790.

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

DX-D Imaging Package with XD Detectors received FDA 510(k) clearance on 2021-07-30, under approval number K211790.

What company makes DX-D Imaging Package with XD Detectors?

DX-D Imaging Package with XD Detectors is manufactured by Agfa N.V..

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

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

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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.

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