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FDA 510(k)

数字放射摄影系统(MobileApex 60E,MobileApex 60F,MobileApex 60G,MobileApex 60H)

K号: K240284 · 2024-03-28

决定日期2024-03-28
产品代码IZL
咨询委员会RA
决定实质等同

器械摘要

Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Browiner Tech Co., Ltd.. It received FDA 510(k) clearance on 2024-03-28 under 510(k) number K240284. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)?

Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) is a medical device that received FDA 510(k) clearance on 2024-03-28. The listed applicant is Shenzhen Browiner Tech Co., Ltd.. The 510(k) number is K240284.

When did Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) receive FDA 510(k) clearance?

Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) received FDA 510(k) clearance on 2024-03-28, under 510(k) number K240284.

Who is the listed applicant for Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)?

The FDA 510(k) record lists Shenzhen Browiner Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)?

The FDA product code for Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) is IZL.

相关临床试验

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。

列明Shenzhen Browiner Tech Co., 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:IZL)

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。

官方来源

在 FDA 数据库中查看 →

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