FDA 510(k)

Aplio beyond和Aplio me软件V2.0诊断超声系统

K号: K253597 · 2026-01-20

决定日期2026-01-20

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Aplio beyond and Aplio me Software V2.0 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 2026-01-20 under 510(k) number K253597. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System?

Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2026-01-20. The listed applicant is Canon Medical Systems Corporation. The 510(k) number is K253597.

When did Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System receive FDA 510(k) clearance?

Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System received FDA 510(k) clearance on 2026-01-20, under 510(k) number K253597.

Who is the listed applicant for Aplio beyond and Aplio me Software V2.0 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 beyond and Aplio me Software V2.0 Diagnostic Ultrasound System?

The FDA product code for Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System is IYN.

列明Canon Medical Systems Corporation为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0 K253625Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 配备 AiCE 重建处理单元的核磁共振成像设备 K260078Aquilion ServeSP (TSX-307B) V2.0 K253584Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)K251370Cartesion Prime (PCD-1000A/3) V10.21 K252074Aplio i900，Aplio i800和Aplio i700软件V9.0诊断超声系统

查看所有 97 个设备 →

相关器械（代码：IYN）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

官方来源

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