FDA 510(k)

伽馬波輻射治療系統

K 號：K180571 · 2018-04-04

決定日期2018-04-04

產品代碼IWB

諮詢委員會RA

決定相當於

器材摘要

GammaPod is the device name listed in this FDA 510(k) record. The listed applicant is Xcision Medical Systems, LLC. It received FDA 510(k) clearance on 2018-04-04 under 510(k) number K180571. 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 GammaPod?

GammaPod is a medical device that received FDA 510(k) clearance on 2018-04-04. The listed applicant is Xcision Medical Systems, LLC. The 510(k) number is K180571.

When did GammaPod receive FDA 510(k) clearance?

GammaPod received FDA 510(k) clearance on 2018-04-04, under 510(k) number K180571.

Who is the listed applicant for GammaPod?

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

What is the FDA product code for GammaPod?

The FDA product code for GammaPod is IWB.

其他以 Xcision Medical Systems, LLC 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。

K172706GammaPod - 模型 A

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 K203146Akesis Galaxy RTiAkesis, Inc.K200050Akesis Galaxy RTxAkesis, Inc.

官方來源

在 FDA 資料庫中查看 →

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。