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FDA 510(k)

Vitrea Advanced Visualization, Version 7.6

K-Number: K172855 · 2017-10-05

ApplicantVital Images, Inc.
Decision Date2017-10-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vitrea Advanced Visualization, Version 7.6 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 2017-10-05 under 510(k) number K172855. 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 Advanced Visualization, Version 7.6?

Vitrea Advanced Visualization, Version 7.6 is a medical device that received FDA 510(k) clearance on 2017-10-05. The listed applicant is Vital Images, Inc.. The 510(k) number is K172855.

When did Vitrea Advanced Visualization, Version 7.6 receive FDA 510(k) clearance?

Vitrea Advanced Visualization, Version 7.6 received FDA 510(k) clearance on 2017-10-05, under 510(k) number K172855.

Who is the listed applicant for Vitrea Advanced Visualization, Version 7.6?

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 Advanced Visualization, Version 7.6?

The FDA product code for Vitrea Advanced Visualization, Version 7.6 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.

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Related Devices (Code: LLZ)

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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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