FDA 510(k)

IntraSight Plus

K 號：K253714 · 2026-02-24

申請人Philips Image Guided Therapy Corporation

決定日期2026-02-24

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

IntraSight Plus is the device name listed in this FDA 510(k) record. The listed applicant is Philips Image Guided Therapy Corporation. It received FDA 510(k) clearance on 2026-02-24 under 510(k) number K253714. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IntraSight Plus?

IntraSight Plus is a medical device that received FDA 510(k) clearance on 2026-02-24. The listed applicant is Philips Image Guided Therapy Corporation. The 510(k) number is K253714.

When did IntraSight Plus receive FDA 510(k) clearance?

IntraSight Plus received FDA 510(k) clearance on 2026-02-24, under 510(k) number K253714.

Who is the listed applicant for IntraSight Plus?

The FDA 510(k) record lists Philips Image Guided Therapy Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IntraSight Plus?

The FDA product code for IntraSight Plus is IYO.

其他以 Philips Image Guided Therapy 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。

K251103VeriSight 心內超聲心臟內穿刺針 (VSICE2D)；VeriSight Pro 心內超聲心臟內穿刺針 (VSICE3D)K200812VeriSight 心內超聲內心臟內心導管，VeriSight Pro 心內超聲內心臟內心導管 K200410Reconnaissance PV .018 OTW Digital IVUS Catheter

相關器械（代碼：IYO）

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。

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官方來源

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