FDA 510(k)

MRIdian Linac 系統配備 138 片葉子攝影機

K 號：K170751 · 2017-06-07

決定日期2017-06-07

產品代碼IYE

諮詢委員會RA

決定相當於

器材摘要

MRIdian Linac System with 138-leaf Collimator is the device name listed in this FDA 510(k) record. The listed applicant is Viewray, Incorporated. It received FDA 510(k) clearance on 2017-06-07 under 510(k) number K170751. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MRIdian Linac System with 138-leaf Collimator?

MRIdian Linac System with 138-leaf Collimator is a medical device that received FDA 510(k) clearance on 2017-06-07. The listed applicant is Viewray, Incorporated. The 510(k) number is K170751.

When did MRIdian Linac System with 138-leaf Collimator receive FDA 510(k) clearance?

MRIdian Linac System with 138-leaf Collimator received FDA 510(k) clearance on 2017-06-07, under 510(k) number K170751.

Who is the listed applicant for MRIdian Linac System with 138-leaf Collimator?

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

What is the FDA product code for MRIdian Linac System with 138-leaf Collimator?

The FDA product code for MRIdian Linac System with 138-leaf Collimator is IYE.

其他以 Viewray, Incorporated 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。

K212958MRIdian 線束系統 K181989MRIdian 線束系統 K162393ViewRay (MRIdian) 靈子系統

相關器械（代碼：IYE）

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。

K261865AerFrame™ 對齊雷射箱 (LBV2)Stabilix, LLC K261718EZFluence (RADEZ V2)Radformation, Inc.K260733MRIA 放射治療資訊系統 (MRIA)Manteia Technologies Co., Ltd.K261856Halcyon, Ethos 放射治療系統 (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SA K253004LUNA 3DLap GmbH Laser Applikationen

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。