Focus HD 35 检测器
K号: K213646 · 2022-03-29
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器械摘要
Focus HD 35 Detector is the device name listed in this FDA 510(k) record. The listed applicant is Iray Technology Taicang , Ltd.. It received FDA 510(k) clearance on 2022-03-29 under 510(k) number K213646. 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 Focus HD 35 Detector?
Focus HD 35 Detector is a medical device that received FDA 510(k) clearance on 2022-03-29. The listed applicant is Iray Technology Taicang , Ltd.. The 510(k) number is K213646.
When did Focus HD 35 Detector receive FDA 510(k) clearance?
Focus HD 35 Detector received FDA 510(k) clearance on 2022-03-29, under 510(k) number K213646.
Who is the listed applicant for Focus HD 35 Detector?
The FDA 510(k) record lists Iray Technology Taicang , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Focus HD 35 Detector?
The FDA product code for Focus HD 35 Detector is MQB.
相关临床试验
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列明Iray Technology Taicang , Ltd.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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