FDA 510(k)

ExactVu 高解析度微超聲系統

K 號：K180636 · 2018-04-30

決定日期2018-04-30

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

ExactVu High Resolution Micro-Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Exact Imaging, Inc.. It received FDA 510(k) clearance on 2018-04-30 under 510(k) number K180636. 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 ExactVu High Resolution Micro-Ultrasound System?

ExactVu High Resolution Micro-Ultrasound System is a medical device that received FDA 510(k) clearance on 2018-04-30. The listed applicant is Exact Imaging, Inc.. The 510(k) number is K180636.

When did ExactVu High Resolution Micro-Ultrasound System receive FDA 510(k) clearance?

ExactVu High Resolution Micro-Ultrasound System received FDA 510(k) clearance on 2018-04-30, under 510(k) number K180636.

Who is the listed applicant for ExactVu High Resolution Micro-Ultrasound System?

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

What is the FDA product code for ExactVu High Resolution Micro-Ultrasound System?

The FDA product code for ExactVu High Resolution Micro-Ultrasound System is IYO.

其他以 Exact Imaging, 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。

K192303ExactVu 高解析度微超聲系統 K190995ExactVu 高解析度微超聲系統

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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