FDA 510(k)

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™)

K 號：K250391 · 2025-07-02

決定日期2025-07-02

產品代碼IWB

諮詢委員會RA

決定相當於

器材摘要

Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) is the device name listed in this FDA 510(k) record. The listed applicant is Elekta Solutions AB. It received FDA 510(k) clearance on 2025-07-02 under 510(k) number K250391. 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 Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)?

Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) is a medical device that received FDA 510(k) clearance on 2025-07-02. The listed applicant is Elekta Solutions AB. The 510(k) number is K250391.

When did Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) receive FDA 510(k) clearance?

Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) received FDA 510(k) clearance on 2025-07-02, under 510(k) number K250391.

Who is the listed applicant for Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)?

FDA 510(k) 記錄將 Elekta Solutions AB 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)?

The FDA product code for Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) is IWB.

其他以 Elekta Solutions AB 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。

K261932萊克塞爾® Vantage 積極定位系統 K252002Monaco RTP系統（6.3）K252188EMLA (Elekta Evo)；EMLA (VersaHD)；EMLA (Elekta Harmony Pro)；EMLA (Elekta Infintiy)；EMLA (Elekta Harmony)；EMLA (Elekta Synergy)K251363ProKnow DS K232854萊克塞爾伽馬計劃（LGP）K223229MOSAIQ® OIS（腫瘤資訊系統）

查看所有 15 項裝置 →

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。

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.K190844Akesis GalaxyAkesis, 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。