FDA 510(k)

Lumify 診斷超音波系統

K 號：K223771 · 2023-05-04

決定日期2023-05-04

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Lumify Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Philips Ultrasound. It received FDA 510(k) clearance on 2023-05-04 under 510(k) number K223771. 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 Lumify Diagnostic Ultrasound System?

Lumify Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2023-05-04. The listed applicant is Philips Ultrasound. The 510(k) number is K223771.

When did Lumify Diagnostic Ultrasound System receive FDA 510(k) clearance?

Lumify Diagnostic Ultrasound System received FDA 510(k) clearance on 2023-05-04, under 510(k) number K223771.

Who is the listed applicant for Lumify Diagnostic Ultrasound System?

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

What is the FDA product code for Lumify Diagnostic Ultrasound System?

The FDA product code for Lumify Diagnostic Ultrasound System is IYN.

其他以 Philips Ultrasound 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。

K242519Lumify 診斷超音波系統 K242670Lumify 診斷超音波系統 K232500Lumify 診斷超音波系統

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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