FDA 510(k)

Yomi Robotic System

K-Number: K222049 · 2022-11-04

Decision Date2022-11-04

Product CodeQRY

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Yomi Robotic System is the device name listed in this FDA 510(k) record. The listed applicant is Neocis, Inc.. It received FDA 510(k) clearance on 2022-11-04 under 510(k) number K222049. The device is classified under product code QRY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Yomi Robotic System?

Yomi Robotic System is a medical device that received FDA 510(k) clearance on 2022-11-04. The listed applicant is Neocis, Inc.. The 510(k) number is K222049.

When did Yomi Robotic System receive FDA 510(k) clearance?

Yomi Robotic System received FDA 510(k) clearance on 2022-11-04, under 510(k) number K222049.

Who is the listed applicant for Yomi Robotic System?

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

What is the FDA product code for Yomi Robotic System?

The FDA product code for Yomi Robotic System is QRY.

Other records listing Neocis, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252376Yomi S Robotic System K251835Yomi Robotic System K231018Yomi Robotic System K222750Yomi Robotic System K211466Yomi Robotic System with YomiPlan Go K210711Neocis Guidance System (NGS) with Yomi Plan v2.0.1

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Related Devices (Code: QRY)

K232148X-Guide Surgical Navigation SystemX-Nav Technologies, LLC K222750Yomi Robotic SystemNeocis, Inc.K211701X-Guide® Surgical Navigation SystemX-Nav Technologies, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.