FDA 510(k)

7600 超聲系統 (MyLabC25); 7600 超聲系統 (MyLabC30)

K 號：K253310 · 2025-11-25

決定日期2025-11-25

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) 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 2025-11-25 under 510(k) number K253310. 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 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)?

7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) is a medical device that received FDA 510(k) clearance on 2025-11-25. The listed applicant is Esaote, S.p.A.. The 510(k) number is K253310.

When did 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) receive FDA 510(k) clearance?

7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) received FDA 510(k) clearance on 2025-11-25, under 510(k) number K253310.

Who is the listed applicant for 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)?

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 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)?

The FDA product code for 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) 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）K2432536600 超聲系統 (MyLabA50)；6600 超聲系統 (MyLabA70)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

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