FDA 510(k)

6600 超聲系統 (MyLabA50)；6600 超聲系統 (MyLabA70)

K 號：K243253 · 2025-06-18

決定日期2025-06-18

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) is the device name listed in this FDA 510(k) record. The listed applicant is Esaote, S.p.A.. It received FDA 510(k) clearance on 2025-06-18 under 510(k) number K243253. 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 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)?

6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) is a medical device that received FDA 510(k) clearance on 2025-06-18. The listed applicant is Esaote, S.p.A.. The 510(k) number is K243253.

When did 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) receive FDA 510(k) clearance?

6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) received FDA 510(k) clearance on 2025-06-18, under 510(k) number K243253.

Who is the listed applicant for 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)?

FDA 510(k) 記錄將 Esaote, S.p.A. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)?

The FDA product code for 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) is IYN.

其他以 Esaote, S.p.A. 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。

K261331I-Genius (100019400)K2532886450 超聲系統 (MyLabE80)；6450 超聲系統 (MyLabE85)K260746S-scan 開放 (100001800)K251901麥格尼可開放式（100009900）K2533107600 超聲系統 (MyLabC25); 7600 超聲系統 (MyLabC30)K2416716450 超聲系統 (MyLabE80)；6450 超聲系統 (MyLabE85)

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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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。