FDA 510(k)

CX50 診斷超音波系統，Sparq 診斷超音波系統

K 號：K162329 · 2016-09-14

決定日期2016-09-14

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Philips Health Care. It received FDA 510(k) clearance on 2016-09-14 under 510(k) number K162329. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System?

CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-09-14. The listed applicant is Philips Health Care. The 510(k) number is K162329.

When did CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System receive FDA 510(k) clearance?

CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System received FDA 510(k) clearance on 2016-09-14, under 510(k) number K162329.

Who is the listed applicant for CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System?

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

What is the FDA product code for CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System?

The FDA product code for CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System is IYN.

其他以 Philips Health Care 為申請人之記錄

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K2013523D自動LAA K200974QLAB先進量化軟體 K200179合作即時 K191647QLAB先進量化軟體 K192226Lumify 診斷超音波系統 K190913QLAB先進量化軟體 13

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相關器械（代碼：IYN）

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。

官方來源

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