510(k) · Cleared
ClearedX-Guide Surgical Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
X-Nav Technologies, LLC · QRY Dental Navigation System
Cleared on Aug 28, 2026 as substantially equivalent to K232148 (X-Nav Technologies, LLC, 2024) after a 261-day review. Its family tree reaches back 6 generations to 1999.
- Decided
- Aug 28, 2026
- Review
- 261 days
- Class
- Class II
- Product code
- QRY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K983831 (1999). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 5 generations backK023424 Igi-SystemDenx Advanced Dental Systems · 2003
- 4 generations backK150222 X-Guide Surgical Navigation SystemX-Nav Technologies, LLC · 2015 · Recalled
- 3 generations backK192579 X-Guide Surgical Navigation SystemX-Nav Technologies, LLC · 2020
- 2 generations backK211701 X-Guide® Surgical Navigation SystemX-Nav Technologies, LLC · 2022 · Recalled
- 1 generation backK232148 X-Guide Surgical Navigation SystemX-Nav Technologies, LLC · 2024 · Recalled
- This deviceK253954 X-Guide Surgical Navigation SystemX-Nav Technologies, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −5 | K023424 | Igi-System | Denx Advanced Dental Systems | 2003 | — |
| −4 | K150222 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | 2015 | 1 |
| −3 | K192579 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | 2020 | — |
| −2 | K211701 | X-Guide® Surgical Navigation System | X-Nav Technologies, LLC | 2022 | 1 |
| −1 | K232148 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | 2024 | 2 |
| 0 (this device) | K253954 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QRY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QRY device
- #1 K222750 Yomi Robotic Systemscore 9.3 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K232148 | X-Guide Surgical Navigation SystemSummary page 5…II Product Code: QRY, PLV Predicate Device: X-Guide® Surgical Navigation System (K232148) Reference Devices: X-Guide® Surgical Navigation System (K150222, K200662, K192579, K211071)… | 2024 |
| † | K150222 | X-Guide Surgical Navigation System | 2015 |
| † | K200662 | X-Guide® Surgical Navigation System | 2020 |
| † | K192579 | X-Guide Surgical Navigation System | 2020 |
| † | K211071 | X-Guide® Surgical Navigation System | |
| † | K233563 | Navident | 2024 |
| † | K210947 | Navident | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 3 of the 7 ancestors have a recall of any class.
How does its category compare?
All QRY devicesQRY Dental Navigation System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QRY
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QRY
115in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QRY
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QRY
2in 2024
MAUDE reports naming product code QRY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 3 | 115 | 1 | 0 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The X-Guide® Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures and/or endodontic access procedures. The system provides software to preoperatively plan dental implantation procedures and/or endodontics access procedures and provides navigational guidance of the surgical instruments. The device is…
Read the full statement (109 words)
The X-Guide® Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures and/or endodontic access procedures.
The system provides software to preoperatively plan dental implantation procedures and/or endodontics access procedures and provides navigational guidance of the surgical instruments.
The device is intended for use for partially edentulous and edentulous adult and geriatric patients who need dental implants as a part of their treatment plan. The device is also intended for endodontic access procedures (i.e., apicoectomies and/or access of calcified canals) where a CBCT is deemed appropriate as part of their treatment plan.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253954 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253954: X-Guide Surgical Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253954
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026