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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 the device name listed in this FDA 510(k) record. The listed applicant is Agfa N.V.. It received FDA 510(k) clearance on 2021-07-30 under 510(k) 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. The listed applicant is Agfa N.V.. The 510(k) number is K211790.

When did DX-D Imaging Package with XD Detectors receive FDA 510(k) clearance?

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

Who is the listed applicant for DX-D Imaging Package with XD Detectors?

The FDA 510(k) record lists Agfa N.V. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Agfa N.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213469VALORYK212145DR 800 with DSA, DR 800K193262DR 600 with TomosynthesisK191884DR 100sK183275DR 800 with Tomosynthesis

Related Devices (Code: MQB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, 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.

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