FDA 510(k)

發現NM/CT 670 CZT

K 號：K153402 · 2016-01-21

決定日期2016-01-21

產品代碼KPS

諮詢委員會RA

決定相當於

器材摘要

Discovery NM/CT 670 CZT is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2016-01-21 under 510(k) number K153402. 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 Discovery NM/CT 670 CZT?

Discovery NM/CT 670 CZT is a medical device that received FDA 510(k) clearance on 2016-01-21. The listed applicant is GE Healthcare. The 510(k) number is K153402.

When did Discovery NM/CT 670 CZT receive FDA 510(k) clearance?

Discovery NM/CT 670 CZT received FDA 510(k) clearance on 2016-01-21, under 510(k) number K153402.

Who is the listed applicant for Discovery NM/CT 670 CZT?

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

What is the FDA product code for Discovery NM/CT 670 CZT?

The FDA product code for Discovery NM/CT 670 CZT is KPS.

其他以 GE Healthcare 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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