FDA 510(k)

MEVION S250i 非線性加速器質子線治療儀

K 號：K172848 · 2017-12-27

決定日期2017-12-27

產品代碼LHN

諮詢委員會RA

決定相當於

器材摘要

MEVION S250i Proton Beam Radiation Therapy Device is the device name listed in this FDA 510(k) record. The listed applicant is Mevion Medical Systems. It received FDA 510(k) clearance on 2017-12-27 under 510(k) number K172848. 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 MEVION S250i Proton Beam Radiation Therapy Device?

MEVION S250i Proton Beam Radiation Therapy Device is a medical device that received FDA 510(k) clearance on 2017-12-27. The listed applicant is Mevion Medical Systems. The 510(k) number is K172848.

When did MEVION S250i Proton Beam Radiation Therapy Device receive FDA 510(k) clearance?

MEVION S250i Proton Beam Radiation Therapy Device received FDA 510(k) clearance on 2017-12-27, under 510(k) number K172848.

Who is the listed applicant for MEVION S250i Proton Beam Radiation Therapy Device?

The FDA 510(k) record lists Mevion Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEVION S250i Proton Beam Radiation Therapy Device?

The FDA product code for MEVION S250i Proton Beam Radiation Therapy Device is LHN.

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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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：LHN）

官方來源