FDA 510(k)

数字无线口腔X射线传感器

K号: K230998 · 2023-10-20

申请人Iray Imaging Technology (Haining) Limited

决定日期2023-10-20

产品代码MUH

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决定实质等同

器械摘要

Digital Wireless Intraoral X-Ray Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Iray Imaging Technology (Haining) Limited. It received FDA 510(k) clearance on 2023-10-20 under 510(k) number K230998. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Digital Wireless Intraoral X-Ray Sensor?

Digital Wireless Intraoral X-Ray Sensor is a medical device that received FDA 510(k) clearance on 2023-10-20. The listed applicant is Iray Imaging Technology (Haining) Limited. The 510(k) number is K230998.

When did Digital Wireless Intraoral X-Ray Sensor receive FDA 510(k) clearance?

Digital Wireless Intraoral X-Ray Sensor received FDA 510(k) clearance on 2023-10-20, under 510(k) number K230998.

Who is the listed applicant for Digital Wireless Intraoral X-Ray Sensor?

The FDA 510(k) record lists Iray Imaging Technology (Haining) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital Wireless Intraoral X-Ray Sensor?

The FDA product code for Digital Wireless Intraoral X-Ray Sensor is MUH.

列明Iray Imaging Technology (Haining) Limited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。

K252911Lux HD 2530 探测器 (Lux HD 2530)K243556Lux HD 35 探测器 (Lux HD 35)；Lux HD 43 探测器 (Lux HD 43)K230811数字口腔内X射线传感器

官方来源

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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。