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FDA 510(k)

Ez3D Plus

K-Number: K152746 · 2016-01-03

ApplicantEwoosoft Co., Ltd.
Decision Date2016-01-03
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ez3D Plus is a medical device manufactured by Ewoosoft Co., Ltd.. It received FDA 510(k) clearance on 2016-01-03 under approval number K152746. 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 Ez3D Plus?

Ez3D Plus is a medical device that received FDA 510(k) clearance on 2016-01-03. It is manufactured by Ewoosoft Co., Ltd.. The 510(k) number is K152746.

When was Ez3D Plus approved by the FDA?

Ez3D Plus received FDA 510(k) clearance on 2016-01-03, under approval number K152746.

What company makes Ez3D Plus?

Ez3D Plus is manufactured by Ewoosoft Co., Ltd..

What is the FDA product code for Ez3D Plus?

The FDA product code for Ez3D Plus is LLZ.

Other Devices by Ewoosoft Co., Ltd.

K163539Ez3D-i / E3 K161246Ez3D-i / E3 K161117EzDent-i / E2 / Prora View K173094OrthoVision K172364EzDent-i / E2 / Prora View K163533EzDent-i; E2; ProraView

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Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

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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