FDA 510(k)

Klarity SGRT 系統（ARSG-E1A，ARSG-E3A）

K 號：K241937 · 2025-03-18

申請人Klarity Medical & Equipment (GZ) Co., Ltd.

決定日期2025-03-18

產品代碼IYE

諮詢委員會RA

決定相當於

器材摘要

Klarity SGRT System (ARSG-E1A, ARSG-E3A) is the device name listed in this FDA 510(k) record. The listed applicant is Klarity Medical & Equipment (GZ) Co., Ltd.. It received FDA 510(k) clearance on 2025-03-18 under 510(k) number K241937. 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 Klarity SGRT System (ARSG-E1A, ARSG-E3A)?

Klarity SGRT System (ARSG-E1A, ARSG-E3A) is a medical device that received FDA 510(k) clearance on 2025-03-18. The listed applicant is Klarity Medical & Equipment (GZ) Co., Ltd.. The 510(k) number is K241937.

When did Klarity SGRT System (ARSG-E1A, ARSG-E3A) receive FDA 510(k) clearance?

Klarity SGRT System (ARSG-E1A, ARSG-E3A) received FDA 510(k) clearance on 2025-03-18, under 510(k) number K241937.

Who is the listed applicant for Klarity SGRT System (ARSG-E1A, ARSG-E3A)?

The FDA 510(k) record lists Klarity Medical & Equipment (GZ) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Klarity SGRT System (ARSG-E1A, ARSG-E3A)?

The FDA product code for Klarity SGRT System (ARSG-E1A, ARSG-E3A) is IYE.

其他以 Klarity Medical & Equipment (GZ) Co., Ltd. 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。

K220539Klarity SRS 底板，Klarity Promise 底板 K202747Klarity 靜脈注射劑

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。