510(k) K253954
- Device
- X-Guide Surgical Navigation System
- Applicant
- X-Nav Technologies, LLC
- 510(k) number
- K253954
- Product code
- QRY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-08-28
- Date received
- 2025-12-10
- 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
- N
Applicant Contact#
- Contact
- Kimberly Chan
- Address
- 1555 Bustard Rd. Suite 75 & 110 Lansdale PA US 19446 19446
FDA Registration Numbers#
- 3011874573
- 3012787974
- 3014552222
- 3011764595
Source Documents#
Other 510(k) Records For Product Code QRY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232148 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | 2024-02-21 |
| K222750 | Yomi Robotic System | Neocis, Inc. | 2022-12-08 |
| K222049 | Yomi Robotic System | Neocis, Inc. | 2022-11-04 |
| K211701 | X-Guide® Surgical Navigation System | X-Nav Technologies, LLC | 2022-02-01 |