FDA.reportPublic FDA data

510(k) K211701

Device
X-Guide® Surgical Navigation System
Applicant
X-Nav Technologies, LLC
510(k) number
K211701
Product code
QRY
Decision
Substantially Equivalent (SESE)
Decision date
2022-02-01
Date received
2021-06-03
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
Kimberly Chan
Address
1555 Bustard Rd. Suite 75 Lansdale PA US 19446 19446

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
K222049Yomi Robotic SystemNeocis, Inc.2022-11-04