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FDA 510(k)

3D-RD-S

K号: K212587 · 2023-02-22

决定日期2023-02-22
产品代码IYX
咨询委员会RA
决定实质等同

器械摘要

3D-RD-S is the device name listed in this FDA 510(k) record. The listed applicant is Radiopharmaceutical Imaging and Dosimetry, LLC. It received FDA 510(k) clearance on 2023-02-22 under 510(k) number K212587. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

什么是3D-RD-S?

3D-RD-S is a medical device that received FDA 510(k) clearance on 2023-02-22. The listed applicant is Radiopharmaceutical Imaging and Dosimetry, LLC. The 510(k) number is K212587.

3D-RD-S何时获得FDA 510(k)批准?

3D-RD-S received FDA 510(k) clearance on 2023-02-22, under 510(k) number K212587.

3D-RD-S的列名申请人是谁?

The FDA 510(k) record lists Radiopharmaceutical Imaging and Dosimetry, LLC as the applicant. This does not by itself establish the device manufacturer.

3D-RD-S的FDA产品代码是什么?

The FDA product code for 3D-RD-S is IYX.

列明Radiopharmaceutical Imaging and Dosimetry, 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:IYX)

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 →

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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