FDA 510(k)

EPIQ 系列诊断超声系统; Affiniti 系列诊断超声系统

K号: K260680 · 2026-05-27

决定日期2026-05-27

产品代码IYN

咨询委员会RA

决定Substantially Equivalent

器械摘要

EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems is the device name listed in this FDA 510(k) record. The listed applicant is Philips Ultrasound, LLC. It received FDA 510(k) clearance on 2026-05-27 under 510(k) number K260680. 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 EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems?

EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems is a medical device that received FDA 510(k) clearance on 2026-05-27. The listed applicant is Philips Ultrasound, LLC. The 510(k) number is K260680.

When did EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems receive FDA 510(k) clearance?

EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems received FDA 510(k) clearance on 2026-05-27, under 510(k) number K260680.

Who is the listed applicant for EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems?

The FDA 510(k) record lists Philips Ultrasound, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems?

The FDA product code for EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems is IYN.

列明Philips Ultrasound, LLC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。

K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System K262311Alturion系列诊断超声系统 K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System K260667Alturion系列诊断超声系统 K260123EPIQ 系列诊断超声系统 K252558Lumify 诊断超声系统

查看所有 27 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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