FDA 510(k)

ULTIMUS系列超聲診斷系統

K 號：K240676 · 2024-12-16

決定日期2024-12-16

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

ULTIMUS Series Ultrasound Diagnostic System is the device name listed in this FDA 510(k) record. The listed applicant is Vinno Technology (Suzhou) Co.,Ltd. It received FDA 510(k) clearance on 2024-12-16 under 510(k) number K240676. 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 ULTIMUS Series Ultrasound Diagnostic System?

ULTIMUS Series Ultrasound Diagnostic System is a medical device that received FDA 510(k) clearance on 2024-12-16. The listed applicant is Vinno Technology (Suzhou) Co.,Ltd. The 510(k) number is K240676.

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

ULTIMUS Series Ultrasound Diagnostic System received FDA 510(k) clearance on 2024-12-16, under 510(k) number K240676.

Who is the listed applicant for ULTIMUS Series Ultrasound Diagnostic System?

The FDA 510(k) record lists Vinno Technology (Suzhou) Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTIMUS Series Ultrasound Diagnostic System?

The FDA product code for ULTIMUS Series Ultrasound Diagnostic System is IYN.

其他以 Vinno Technology (Suzhou) Co.,Ltd 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。

K230160VINNO G86、VINNO G86E、VINNO G65、VINNO G65P、VINNO G65E、VINNO G65D、VINNO M86、VINNO M86E、VINNO G90、VINNO G90E K223917VINNO E20、VINNO E10、VINNO E10P、VINNO E10E、VINNO X1、VINNO X1E、VINNO X1P、VINNO X2、VINNO X2E、VINNO X2P K223920VINNO G50、VINNO G55、VINNO M50、VINNO E30、VINNO X5、VINNO X6、VINNO X7、VINNO M55、VINNO E35、VINNO X65、VINNO X55、VINNO X35、VINNO G55E、VINNO G55P、VINNO M55E、VINNO M55P、VINNO E35E、VINNO E35P K221911VINNO 6PRO、VINNO 6EXP、VINNO 5PRO、VINNO 5EXP、VINNO 3、VINNO 3PRO、VINNO 3EXP K190120VINNO 8, VINNO 6, VINNO 5

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。

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