DX-D Imaging Package with XD Detectors
K号: K211790 · 2021-07-30
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器械摘要
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.
常见问题
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.
相关临床试验
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列明Agfa N.V.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：MQB）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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