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FDA 510(k)

syngo®.via protoNeo (Version VA10A)

K-Number: K161685 · 2016-07-11

ApplicantSiemens Healthcare GmbH
Decision Date2016-07-11
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo®.via protoNeo (Version VA10A) 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 2016-07-11 under 510(k) number K161685. 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 protoNeo (Version VA10A)?

syngo®.via protoNeo (Version VA10A) is a medical device that received FDA 510(k) clearance on 2016-07-11. The listed applicant is Siemens Healthcare GmbH. The 510(k) number is K161685.

When did syngo®.via protoNeo (Version VA10A) receive FDA 510(k) clearance?

syngo®.via protoNeo (Version VA10A) received FDA 510(k) clearance on 2016-07-11, under 510(k) number K161685.

Who is the listed applicant for syngo®.via protoNeo (Version VA10A)?

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 protoNeo (Version VA10A)?

The FDA product code for syngo®.via protoNeo (Version VA10A) is LLZ.

Other records listing Siemens Healthcare GmbH 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.

K253264myAblation Guide (VC10A)K253689syngo Dynamics (VA41F)K252548AI-Rad Companion Organs RTK253057AI-Rad Companion Brain MRK252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.RiseK252608AI-Rad Companion Prostate MR

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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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