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FDA 510(k)

AcroDTI Visualizer

K-Number: K201948 · 2020-09-09

ApplicantAcroviz, Inc.
Decision Date2020-09-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AcroDTI Visualizer is a medical device manufactured by Acroviz, Inc.. It received FDA 510(k) clearance on 2020-09-09 under approval number K201948. 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 AcroDTI Visualizer?

AcroDTI Visualizer is a medical device that received FDA 510(k) clearance on 2020-09-09. It is manufactured by Acroviz, Inc.. The 510(k) number is K201948.

When was AcroDTI Visualizer approved by the FDA?

AcroDTI Visualizer received FDA 510(k) clearance on 2020-09-09, under approval number K201948.

What company makes AcroDTI Visualizer?

AcroDTI Visualizer is manufactured by Acroviz, Inc..

What is the FDA product code for AcroDTI Visualizer?

The FDA product code for AcroDTI Visualizer is LLZ.

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Official Source

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