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FDA 510(k)

Vitrea CT Brain Perfusion

K-Number: K181247 · 2018-11-20

ApplicantVital Images, Inc.
Decision Date2018-11-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vitrea CT Brain Perfusion is the device name listed in this FDA 510(k) record. The listed applicant is Vital Images, Inc.. It received FDA 510(k) clearance on 2018-11-20 under 510(k) number K181247. 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 Vitrea CT Brain Perfusion?

Vitrea CT Brain Perfusion is a medical device that received FDA 510(k) clearance on 2018-11-20. The listed applicant is Vital Images, Inc.. The 510(k) number is K181247.

When did Vitrea CT Brain Perfusion receive FDA 510(k) clearance?

Vitrea CT Brain Perfusion received FDA 510(k) clearance on 2018-11-20, under 510(k) number K181247.

Who is the listed applicant for Vitrea CT Brain Perfusion?

The FDA 510(k) record lists Vital Images, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vitrea CT Brain Perfusion?

The FDA product code for Vitrea CT Brain Perfusion is LLZ.

Other records listing Vital Images, 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.

K182230Multi Modality ViewerK172855Vitrea Advanced Visualization, Version 7.6K163232Vitrea ViewK163574Multi Modality ViewerK161157Vitrea CT Dual Energy Image ViewK161419Multi Modality Viewer

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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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