FDA 510(k)

I-Q 觀察

K 號：K203703 · 2021-03-24

決定日期2021-03-24

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

I-Q View is the device name listed in this FDA 510(k) record. The listed applicant is First Source, Inc.. It received FDA 510(k) clearance on 2021-03-24 under 510(k) number K203703. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the I-Q View?

I-Q View is a medical device that received FDA 510(k) clearance on 2021-03-24. The listed applicant is First Source, Inc.. The 510(k) number is K203703.

When did I-Q View receive FDA 510(k) clearance?

I-Q View received FDA 510(k) clearance on 2021-03-24, under 510(k) number K203703.

Who is the listed applicant for I-Q View?

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

What is the FDA product code for I-Q View?

The FDA product code for I-Q View is MQB.

其他以 First Source, Inc. 為申請人之記錄

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。

K240009iQFlex Pro K221081iQFlex M 移動X光系統，iQFlex MD 移動X光系統

相關器械（代碼：MQB）

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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官方來源

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