FDA 510(k)

6450 超聲系統 (MyLabE80)；6450 超聲系統 (MyLabE85)

K 號：K253288 · 2026-04-06

決定日期2026-04-06

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) 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 2026-04-06 under 510(k) number K253288. 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 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)?

6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) is a medical device that received FDA 510(k) clearance on 2026-04-06. The listed applicant is Esaote, S.p.A.. The 510(k) number is K253288.

When did 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) receive FDA 510(k) clearance?

6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) received FDA 510(k) clearance on 2026-04-06, under 510(k) number K253288.

Who is the listed applicant for 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)?

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 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)?

The FDA product code for 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) 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)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)K2432536600 超聲系統 (MyLabA50)；6600 超聲系統 (MyLabA70)K2416716450 超聲系統 (MyLabE80)；6450 超聲系統 (MyLabE85)

查看所有 25 項裝置 →

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。