FDA 510(k)

軟體異物

K 號：K170345 · 2017-10-27

決定日期2017-10-27

產品代碼IYE

諮詢委員會RA

決定相當於

器材摘要

SOFTDISO is the device name listed in this FDA 510(k) record. The listed applicant is Best Nomos. It received FDA 510(k) clearance on 2017-10-27 under 510(k) number K170345. 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 SOFTDISO?

SOFTDISO is a medical device that received FDA 510(k) clearance on 2017-10-27. The listed applicant is Best Nomos. The 510(k) number is K170345.

When did SOFTDISO receive FDA 510(k) clearance?

SOFTDISO received FDA 510(k) clearance on 2017-10-27, under 510(k) number K170345.

Who is the listed applicant for SOFTDISO?

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

What is the FDA product code for SOFTDISO?

The FDA product code for SOFTDISO is IYE.

其他以 Best Nomos 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。

K211034科烏斯放射治療計劃系統 K201350CORVUS

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

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