FDA 510(k)

syngo.via MI Workflows VB40A, Scenium

K番号: K191309 · 2019-07-19

決定日2019-07-19

製品コードLLZ

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてSiemens Medical Soultions USA, Inc.を記載するその他の記録

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