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FDA 510(k)

True 3D Viewer Software

K-Number: K193149 · 2019-12-27

ApplicantEchopixel, Inc.
Decision Date2019-12-27
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

True 3D Viewer Software is a medical device manufactured by Echopixel, Inc.. It received FDA 510(k) clearance on 2019-12-27 under approval number K193149. 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 Software?

True 3D Viewer Software is a medical device that received FDA 510(k) clearance on 2019-12-27. It is manufactured by Echopixel, Inc.. The 510(k) number is K193149.

When was True 3D Viewer Software approved by the FDA?

True 3D Viewer Software received FDA 510(k) clearance on 2019-12-27, under approval number K193149.

What company makes True 3D Viewer Software?

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

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

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

Other Devices by Echopixel, Inc.

K170167True 3D Viewer Software K201365True 3D Viewer

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Official Source

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