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FDA 510(k)

Ez3D-i / E3

K-Number: K161246 · 2016-05-31

ApplicantEwoosoft Co., Ltd.
Decision Date2016-05-31
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ez3D-i / E3 is a medical device manufactured by Ewoosoft Co., Ltd.. It received FDA 510(k) clearance on 2016-05-31 under approval number K161246. 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-i / E3?

Ez3D-i / E3 is a medical device that received FDA 510(k) clearance on 2016-05-31. It is manufactured by Ewoosoft Co., Ltd.. The 510(k) number is K161246.

When was Ez3D-i / E3 approved by the FDA?

Ez3D-i / E3 received FDA 510(k) clearance on 2016-05-31, under approval number K161246.

What company makes Ez3D-i / E3?

Ez3D-i / E3 is manufactured by Ewoosoft Co., Ltd..

What is the FDA product code for Ez3D-i / E3?

The FDA product code for Ez3D-i / E3 is LLZ.

Other Devices by Ewoosoft Co., Ltd.

K163539Ez3D-i / E3 K161117EzDent-i / E2 / Prora View K152746Ez3D Plus 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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