FDA 510(k)

識別（5.0）

K 號：K252919 · 2025-12-16

決定日期2025-12-16

產品代碼IYE

諮詢委員會RA

決定相當於

器材摘要

IDENTIFY (5.0) is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2025-12-16 under 510(k) number K252919. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IDENTIFY (5.0)?

IDENTIFY (5.0) is a medical device that received FDA 510(k) clearance on 2025-12-16. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K252919.

When did IDENTIFY (5.0) receive FDA 510(k) clearance?

IDENTIFY (5.0) received FDA 510(k) clearance on 2025-12-16, under 510(k) number K252919.

Who is the listed applicant for IDENTIFY (5.0)?

FDA 510(k) 記錄將 Varian Medical Systems, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for IDENTIFY (5.0)?

The FDA product code for IDENTIFY (5.0) is IYE.

其他以 Varian Medical Systems, Inc. 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。

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相關器械（代碼：IYE）

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。

K261865AerFrame™ 對齊雷射箱 (LBV2)Stabilix, LLC K261718EZFluence (RADEZ V2)Radformation, Inc.K260733MRIA 放射治療資訊系統 (MRIA)Manteia Technologies Co., Ltd.K261856Halcyon, Ethos 放射治療系統 (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SA K253004LUNA 3DLap GmbH Laser Applikationen

官方來源

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