FDA 510(k)

Akesis Galaxy RTi

K 號：K203146 · 2021-03-05

決定日期2021-03-05

產品代碼IWB

諮詢委員會RA

決定相當於

器材摘要

Akesis Galaxy RTi is the device name listed in this FDA 510(k) record. The listed applicant is Akesis, Inc.. It received FDA 510(k) clearance on 2021-03-05 under 510(k) number K203146. The device is classified under product code IWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Akesis Galaxy RTi?

Akesis Galaxy RTi is a medical device that received FDA 510(k) clearance on 2021-03-05. The listed applicant is Akesis, Inc.. The 510(k) number is K203146.

When did Akesis Galaxy RTi receive FDA 510(k) clearance?

Akesis Galaxy RTi received FDA 510(k) clearance on 2021-03-05, under 510(k) number K203146.

Who is the listed applicant for Akesis Galaxy RTi?

The FDA 510(k) record lists Akesis, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Akesis Galaxy RTi?

The FDA product code for Akesis Galaxy RTi is IWB.

其他以 Akesis, 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。

K200050Akesis Galaxy RTx K190844Akesis Galaxy

相關器械（代碼：IWB）

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。

K250391萊克塞爾伽馬刀® (Elekta Esprit)；萊克塞爾伽馬刀® (Icon™)；萊克塞爾伽馬刀® (Perfexion™)Elekta Solutions AB K232854萊克塞爾伽馬計劃（LGP）Elekta Solutions AB K222047萊克塞爾伽馬刀Perfexion，萊克塞爾伽馬刀Icon，萊克塞爾伽馬刀 - Elekta Esprit（新型變體）Elekta Solutions AB K203250台灣醫療設備規範文本： TaiChiCOur United Corporation K200050Akesis Galaxy RTxAkesis, Inc.K190844Akesis GalaxyAkesis, Inc.

官方來源

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