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FDA 510(k)

EzOrtho v1.3

K-Number: K220003 · 2022-02-23

ApplicantEwoosoft Co., Ltd.
Decision Date2022-02-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EzOrtho v1.3 is a medical device manufactured by Ewoosoft Co., Ltd.. It received FDA 510(k) clearance on 2022-02-23 under approval number K220003. 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 EzOrtho v1.3?

EzOrtho v1.3 is a medical device that received FDA 510(k) clearance on 2022-02-23. It is manufactured by Ewoosoft Co., Ltd.. The 510(k) number is K220003.

When was EzOrtho v1.3 approved by the FDA?

EzOrtho v1.3 received FDA 510(k) clearance on 2022-02-23, under approval number K220003.

What company makes EzOrtho v1.3?

EzOrtho v1.3 is manufactured by Ewoosoft Co., Ltd..

What is the FDA product code for EzOrtho v1.3?

The FDA product code for EzOrtho v1.3 is LLZ.

Other Devices by Ewoosoft Co., Ltd.

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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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