FDA 510(k)

P-Cure Proton治療系統 (PPTS)

K 號：K242418 · 2025-05-12

決定日期2025-05-12

產品代碼LHN

諮詢委員會RA

決定相當於

器材摘要

P-Cure Proton Therapy System (PPTS) is the device name listed in this FDA 510(k) record. The listed applicant is P-Cure, Ltd.. It received FDA 510(k) clearance on 2025-05-12 under 510(k) number K242418. 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 P-Cure Proton Therapy System (PPTS)?

P-Cure Proton Therapy System (PPTS) is a medical device that received FDA 510(k) clearance on 2025-05-12. The listed applicant is P-Cure, Ltd.. The 510(k) number is K242418.

When did P-Cure Proton Therapy System (PPTS) receive FDA 510(k) clearance?

P-Cure Proton Therapy System (PPTS) received FDA 510(k) clearance on 2025-05-12, under 510(k) number K242418.

Who is the listed applicant for P-Cure Proton Therapy System (PPTS)?

The FDA 510(k) record lists P-Cure, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for P-Cure Proton Therapy System (PPTS)?

The FDA product code for P-Cure Proton Therapy System (PPTS) is LHN.

其他以 P-Cure, Ltd. 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。

K221996P-Cure 鋰子束治療系統 K160611P-ARTIS

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.K252815ProBeam 360 陽子治療系統 v3.0Varian Medical Systems, Inc.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.

官方來源

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