FDA 510(k)

Symbia SPECT 和 SPECT/CT 系统

K号: K241898 · 2024-07-26

决定日期2024-07-26

产品代码KPS

咨询委员会RA

决定实质等同

器械摘要

Symbia SPECT and SPECT/CT Systems is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthineers. It received FDA 510(k) clearance on 2024-07-26 under 510(k) number K241898. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Symbia SPECT and SPECT/CT Systems?

Symbia SPECT and SPECT/CT Systems is a medical device that received FDA 510(k) clearance on 2024-07-26. The listed applicant is Siemens Healthineers. The 510(k) number is K241898.

When did Symbia SPECT and SPECT/CT Systems receive FDA 510(k) clearance?

Symbia SPECT and SPECT/CT Systems received FDA 510(k) clearance on 2024-07-26, under 510(k) number K241898.

Who is the listed applicant for Symbia SPECT and SPECT/CT Systems?

The FDA 510(k) record lists Siemens Healthineers as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Symbia SPECT and SPECT/CT Systems?

The FDA product code for Symbia SPECT and SPECT/CT Systems is KPS.

列明Siemens Healthineers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。

K183575ACUSON S3000, S2000诊断超声系统

相关器械（代码：KPS）

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

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