FDA 510(k)

拉德ialis PET攝影機

K 號：K214062 · 2022-02-04

決定日期2022-02-04

產品代碼KPS

諮詢委員會RA

決定相當於

器材摘要

Radialis PET Camera is the device name listed in this FDA 510(k) record. The listed applicant is Radialis, Inc.. It received FDA 510(k) clearance on 2022-02-04 under 510(k) number K214062. 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 Radialis PET Camera?

Radialis PET Camera is a medical device that received FDA 510(k) clearance on 2022-02-04. The listed applicant is Radialis, Inc.. The 510(k) number is K214062.

When did Radialis PET Camera receive FDA 510(k) clearance?

Radialis PET Camera received FDA 510(k) clearance on 2022-02-04, under 510(k) number K214062.

Who is the listed applicant for Radialis PET Camera?

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

What is the FDA product code for Radialis PET Camera?

The FDA product code for Radialis PET Camera is KPS.

相關器械（代碼：KPS）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：KPS）

官方來源