FDA 510(k)

ProBeam 360 陽子治療系統 v3.0

K 號：K252815 · 2026-04-23

決定日期2026-04-23

產品代碼LHN

諮詢委員會RA

決定相當於

器材摘要

ProBeam 360 Proton Therapy System v3.0 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 2026-04-23 under 510(k) number K252815. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ProBeam 360 Proton Therapy System v3.0?

ProBeam 360 Proton Therapy System v3.0 is a medical device that received FDA 510(k) clearance on 2026-04-23. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K252815.

When did ProBeam 360 Proton Therapy System v3.0 receive FDA 510(k) clearance?

ProBeam 360 Proton Therapy System v3.0 received FDA 510(k) clearance on 2026-04-23, under 510(k) number K252815.

Who is the listed applicant for ProBeam 360 Proton Therapy System v3.0?

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 ProBeam 360 Proton Therapy System v3.0?

The FDA product code for ProBeam 360 Proton Therapy System v3.0 is LHN.

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。

K261856Halcyon, Ethos 放射治療系統 (5.0)K260750虛擬圓錐（1.0）K253026呼吸門控掃描器（2.1）K252304syngo.via RT影像套件 VC10 K252977Halcyon, Ethos 放射治療系統 (5.0)K252919識別（5.0）

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相關器械（代碼：LHN）

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。

K260597VIRTUE QAProNova Solutions K260174PROBEAT-CRHitachi High-Tech Corp.K253406S250-FIT 酸子束放射治療設備（S250-FIT）Mevion Medical Systems, Inc.K250986S250-FIT 酸子束放射治療設備（S250-FIT）Mevion Medical Systems, Inc.K243900eMotus 呼吸動態管理系統Empnia, Inc.K242418P-Cure Proton治療系統 (PPTS)P-Cure, Ltd.

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。