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FDA 510(k)

Q-Rad 系統

K 號:K193574 · 2020-01-22

決定日期2020-01-22
產品代碼KPR
諮詢委員會RA
決定相當於

器材摘要

Q-Rad System is the device name listed in this FDA 510(k) record. The listed applicant is Carestream Health, Inc.. It received FDA 510(k) clearance on 2020-01-22 under 510(k) number K193574. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Q-Rad System?

Q-Rad System is a medical device that received FDA 510(k) clearance on 2020-01-22. The listed applicant is Carestream Health, Inc.. The 510(k) number is K193574.

When did Q-Rad System receive FDA 510(k) clearance?

Q-Rad System received FDA 510(k) clearance on 2020-01-22, under 510(k) number K193574.

Who is the listed applicant for Q-Rad System?

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

What is the FDA product code for Q-Rad System?

The FDA product code for Q-Rad System is KPR.

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其他以 Carestream Health, Inc. 為申請人之記錄

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相關器械(代碼:KPR)

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官方來源

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