FDA 510(k)

Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT

K 號：K162736 · 2016-10-25

決定日期2016-10-25

產品代碼KPS

諮詢委員會RA

決定Substantially Equivalent

器材摘要

Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2016-10-25 under 510(k) number K162736. 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 Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT?

Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT is a medical device that received FDA 510(k) clearance on 2016-10-25. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K162736.

When did Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT receive FDA 510(k) clearance?

Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT received FDA 510(k) clearance on 2016-10-25, under 510(k) number K162736.

Who is the listed applicant for Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT?

The FDA product code for Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT is KPS.

其他以 Siemens Medical Solutions USA, Inc. 為申請人之記錄

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相關器械（代碼：KPS）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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