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FDA 510(k)

OrthoVision

K-Number: K173094 · 2017-10-26

ApplicantEwoosoft Co., Ltd.
Decision Date2017-10-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OrthoVision is the device name listed in this FDA 510(k) record. The listed applicant is Ewoosoft Co., Ltd.. It received FDA 510(k) clearance on 2017-10-26 under 510(k) number K173094. 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 OrthoVision?

OrthoVision is a medical device that received FDA 510(k) clearance on 2017-10-26. The listed applicant is Ewoosoft Co., Ltd.. The 510(k) number is K173094.

When did OrthoVision receive FDA 510(k) clearance?

OrthoVision received FDA 510(k) clearance on 2017-10-26, under 510(k) number K173094.

Who is the listed applicant for OrthoVision?

The FDA 510(k) record lists Ewoosoft Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OrthoVision?

The FDA product code for OrthoVision is LLZ.

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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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