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FDA 510(k)

True 3D Viewer

K-Number: K201365 · 2020-07-17

ApplicantEchopixel, Inc.
Decision Date2020-07-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

True 3D Viewer is a medical device manufactured by Echopixel, Inc.. It received FDA 510(k) clearance on 2020-07-17 under approval number K201365. 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 True 3D Viewer?

True 3D Viewer is a medical device that received FDA 510(k) clearance on 2020-07-17. It is manufactured by Echopixel, Inc.. The 510(k) number is K201365.

When was True 3D Viewer approved by the FDA?

True 3D Viewer received FDA 510(k) clearance on 2020-07-17, under approval number K201365.

What company makes True 3D Viewer?

True 3D Viewer is manufactured by Echopixel, Inc..

What is the FDA product code for True 3D Viewer?

The FDA product code for True 3D Viewer is LLZ.

Other Devices by Echopixel, Inc.

K170167True 3D Viewer Software K193149True 3D Viewer Software

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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