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510(k) K222049

Device
Yomi Robotic System
Applicant
Neocis Inc.
510(k) number
K222049
Product code
QRY  
Decision
Substantially Equivalent (SESE)
Decision date
2022-11-04
Date received
2022-07-12
Regulation
872.4120
Classification name
Dental Navigation System
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Olga Lewis
Address
2800 Biscayne Blvd., Suite 600 Miami FL US 33137 33137

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QRY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232148X-Guide Surgical Navigation SystemX-Nav Technologies, LLC2024-02-21
K222750Yomi Robotic SystemNeocis, Inc.2022-12-08
K211701X-Guide® Surgical Navigation SystemX-Nav Technologies, LLC2022-02-01

Legacy Summary#

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FDA Review#

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