FDA 510(k)

QT超聲乳頭掃描器-1

K 號：K162372 · 2017-06-06

決定日期2017-06-06

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

QT Ultrasound Breast Scanner-1 is the device name listed in this FDA 510(k) record. The listed applicant is Qt Ultrasound, LLC. It received FDA 510(k) clearance on 2017-06-06 under 510(k) number K162372. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the QT Ultrasound Breast Scanner-1?

QT Ultrasound Breast Scanner-1 is a medical device that received FDA 510(k) clearance on 2017-06-06. The listed applicant is Qt Ultrasound, LLC. The 510(k) number is K162372.

When did QT Ultrasound Breast Scanner-1 receive FDA 510(k) clearance?

QT Ultrasound Breast Scanner-1 received FDA 510(k) clearance on 2017-06-06, under 510(k) number K162372.

Who is the listed applicant for QT Ultrasound Breast Scanner-1?

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

What is the FDA product code for QT Ultrasound Breast Scanner-1?

The FDA product code for QT Ultrasound Breast Scanner-1 is IYO.

其他以 Qt Ultrasound, LLC 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。

K190646QT 扫描儀 2000 型號 A K182213QT超聲乳頭掃描儀 - 1

相關器械（代碼：IYO）

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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