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FDA 510(k)

Vitrea CT Colon Analysis

K-Number: K160150 · 2016-03-16

ApplicantVital Images, Inc.
Decision Date2016-03-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vitrea CT Colon Analysis is a medical device manufactured by Vital Images, Inc.. It received FDA 510(k) clearance on 2016-03-16 under approval number K160150. 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 Colon Analysis?

Vitrea CT Colon Analysis is a medical device that received FDA 510(k) clearance on 2016-03-16. It is manufactured by Vital Images, Inc.. The 510(k) number is K160150.

When was Vitrea CT Colon Analysis approved by the FDA?

Vitrea CT Colon Analysis received FDA 510(k) clearance on 2016-03-16, under approval number K160150.

What company makes Vitrea CT Colon Analysis?

Vitrea CT Colon Analysis is manufactured by Vital Images, Inc..

What is the FDA product code for Vitrea CT Colon Analysis?

The FDA product code for Vitrea CT Colon Analysis is 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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