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FDA 510(k)

syngo.via (Version VB40A)

K-Number: K191040 · 2019-05-16

ApplicantSiemens Healthcare GmbH
Decision Date2019-05-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo.via (Version VB40A) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare GmbH. It received FDA 510(k) clearance on 2019-05-16 under 510(k) number K191040. 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 (Version VB40A)?

syngo.via (Version VB40A) is a medical device that received FDA 510(k) clearance on 2019-05-16. The listed applicant is Siemens Healthcare GmbH. The 510(k) number is K191040.

When did syngo.via (Version VB40A) receive FDA 510(k) clearance?

syngo.via (Version VB40A) received FDA 510(k) clearance on 2019-05-16, under 510(k) number K191040.

Who is the listed applicant for syngo.via (Version VB40A)?

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

What is the FDA product code for syngo.via (Version VB40A)?

The FDA product code for syngo.via (Version VB40A) is LLZ.

Other records listing Siemens Healthcare GmbH as applicant

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Related Devices (Code: LLZ)

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

Official Source

View on FDA Database →

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

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