FDA 510(k)

Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System

K 號：K261211 · 2026-07-27

決定日期2026-07-27

產品代碼IYN

諮詢委員會RA

決定Substantially Equivalent

器材摘要

Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System 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 2026-07-27 under 510(k) number K261211. 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 Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System?

Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2026-07-27. The listed applicant is Philips Ultrasound, LLC. The 510(k) number is K261211.

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

Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System received FDA 510(k) clearance on 2026-07-27, under 510(k) number K261211.

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

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 Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System?

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

其他以 Philips Ultrasound, LLC 為申請人之記錄

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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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