FDA 510(k)

Aplio i900, Aplio i800 和 Aplio i700 軟體 V9.0 診斷超聲系統

K 號：K252074 · 2025-10-31

決定日期2025-10-31

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2025-10-31 under 510(k) number K252074. 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 Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System?

Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2025-10-31. The listed applicant is Canon Medical Systems Corporation. The 510(k) number is K252074.

When did Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System receive FDA 510(k) clearance?

Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System received FDA 510(k) clearance on 2025-10-31, under 510(k) number K252074.

Who is the listed applicant for Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System?

The FDA 510(k) record lists Canon Medical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System?

The FDA product code for Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System is IYN.

其他以 Canon Medical Systems Corporation 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。

K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0 K253625Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 搭載 AiCE 重構處理單元的 MRI 設備 K260078Aquilion ServeSP (TSX-307B) V2.0 K253584Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)K253597Aplio beyond 和 Aplio me 軟體 V2.0 診斷超音波系統 K251370卡迪森普萊姆 (PCD-1000A/3) V10.21

查看所有 97 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。