Devices · X-Nav Technologies, LLC

X-Guide Surgical Navigation System

X-Nav Technologies, LLC is listed for X-Guide Surgical Navigation System (K232148). The FDA list gives February 21, 2024 as the date of the final decision. The lead panel is Dental, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QRY as “Dental Navigation System”: Intended to provide real-time guidance on the orientation and location of the dental instrument relative to the patient's anatomy for general dentistry procedures. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232148

Official FDA database record

Date of final decision

February 21, 2024

Company on the FDA list

X-Nav Technologies, LLC

Lead panel

Dental

Primary product code

QRY

openFDA device name for the code

Dental Navigation System

Device class

2

Regulation number

872.4120

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary