Insight Agile DRF
K号: K210469 · 2021-07-27
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器械摘要
Insight Agile DRF is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Engineering, LLC. It received FDA 510(k) clearance on 2021-07-27 under 510(k) number K210469. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Insight Agile DRF?
Insight Agile DRF is a medical device that received FDA 510(k) clearance on 2021-07-27. The listed applicant is Imaging Engineering, LLC. The 510(k) number is K210469.
When did Insight Agile DRF receive FDA 510(k) clearance?
Insight Agile DRF received FDA 510(k) clearance on 2021-07-27, under 510(k) number K210469.
Who is the listed applicant for Insight Agile DRF?
The FDA 510(k) record lists Imaging Engineering, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Insight Agile DRF?
The FDA product code for Insight Agile DRF is JAA.
相关临床试验
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列明Imaging Engineering, LLC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：JAA）
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。
K253103Nexus DRF 数字X射线成像系统Varex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT 移动荧光透视系统Dornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH
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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