FDA 510(k)

Lux HD 2530 探测器 (Lux HD 2530)

K号: K252911 · 2025-10-09

申请人Iray Imaging Technology (Haining) Limited

决定日期2025-10-09

产品代码MQB

咨询委员会RA

决定实质等同

器械摘要

Lux HD 2530 detector (Lux HD 2530) 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 2025-10-09 under 510(k) number K252911. 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 Lux HD 2530 detector (Lux HD 2530)?

Lux HD 2530 detector (Lux HD 2530) is a medical device that received FDA 510(k) clearance on 2025-10-09. The listed applicant is Iray Imaging Technology (Haining) Limited. The 510(k) number is K252911.

When did Lux HD 2530 detector (Lux HD 2530) receive FDA 510(k) clearance?

Lux HD 2530 detector (Lux HD 2530) received FDA 510(k) clearance on 2025-10-09, under 510(k) number K252911.

Who is the listed applicant for Lux HD 2530 detector (Lux HD 2530)?

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 Lux HD 2530 detector (Lux HD 2530)?

The FDA product code for Lux HD 2530 detector (Lux HD 2530) is MQB.

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。

K243556Lux HD 35 探测器 (Lux HD 35)；Lux HD 43 探测器 (Lux HD 43)K230998数字无线口腔X射线传感器 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。