FDA 510(k)

syngo.via MI 工作流程 VB40A, Scenium

K 號：K191309 · 2019-07-19

決定日期2019-07-19

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

syngo.via MI Workflows VB40A, Scenium is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Soultions USA, Inc.. It received FDA 510(k) clearance on 2019-07-19 under 510(k) number K191309. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the syngo.via MI Workflows VB40A, Scenium?

syngo.via MI Workflows VB40A, Scenium is a medical device that received FDA 510(k) clearance on 2019-07-19. The listed applicant is Siemens Medical Soultions USA, Inc.. The 510(k) number is K191309.

When did syngo.via MI Workflows VB40A, Scenium receive FDA 510(k) clearance?

syngo.via MI Workflows VB40A, Scenium received FDA 510(k) clearance on 2019-07-19, under 510(k) number K191309.

Who is the listed applicant for syngo.via MI Workflows VB40A, Scenium?

The FDA 510(k) record lists Siemens Medical Soultions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for syngo.via MI Workflows VB40A, Scenium?

The FDA product code for syngo.via MI Workflows VB40A, Scenium is LLZ.

其他以 Siemens Medical Soultions USA, Inc. 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。

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相關器械（代碼：LLZ）

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。

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