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FDA 510(k)

syngo.via MI Workflows VB40A, Scenium

K-Number: K191309 · 2019-07-19

ApplicantSiemens Medical Soultions USA, Inc.
Decision Date2019-07-19
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Siemens Medical Soultions USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231351Chondral QuantK200515syngo.CT Cardiac Planning

Related Devices (Code: LLZ)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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