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FDA 510(k)

IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)

K 號：K163500 · 2017-08-17

申請人Ion Beam Applications S.A.
決定日期2017-08-17
產品代碼LHN
諮詢委員會RA
決定相當於

器材摘要

IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) is the device name listed in this FDA 510(k) record. The listed applicant is Ion Beam Applications S.A.. It received FDA 510(k) clearance on 2017-08-17 under 510(k) number K163500. 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 IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)?

IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) is a medical device that received FDA 510(k) clearance on 2017-08-17. The listed applicant is Ion Beam Applications S.A.. The 510(k) number is K163500.

When did IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) receive FDA 510(k) clearance?

IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) received FDA 510(k) clearance on 2017-08-17, under 510(k) number K163500.

Who is the listed applicant for IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)?

The FDA 510(k) record lists Ion Beam Applications S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)?

The FDA product code for IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) is LHN.

相關臨床試驗

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：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。

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官方來源

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