FDA 510(k)

Symbia SPECT及SPECT/CT系統

K 號：K241898 · 2024-07-26

決定日期2024-07-26

產品代碼KPS

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

其他以 Siemens Healthineers 為申請人之記錄

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相關器械（代碼：KPS）

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官方來源

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