X-Guide Surgical Navigation System

K232148

X-Nav Technologies, LLC · cleared 2024-02-21 · product code QRY · Dental

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“The proposed change is a software change to integrate a machine learning software trained on varied CT data to segment and identify anatomical structures in a maxillofacial Computer Tomography (CT) scan and in an IntraOral Scan (IOS). The machine learning software performs Automatic Image Processing when a CT or IOS is loaded into the X-Guide System.”
Algorithmmachine learning software trained on varied CT data to segment and identify anatomical structures
source quote (p.6)
“The proposed change is a software change to integrate a machine learning software trained on varied CT data to segment and identify anatomical structures in a maxillofacial Computer Tomography (CT) scan and in an IntraOral Scan (IOS). The machine learning software performs Automatic Image Processing when a CT or IOS is loaded into the X-Guide System.”
Adaptive (vs locked)No
source quote (p.6)
“The software is not adaptive. Rather, it is trained at the manufacturer and the weights are locked.”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.20)
“X-Nav Technologies utilized the following FDA Guidance Documents in the preparation of this 510(k): ... Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”

Validation studies (2)

Bench

sample size not stated

endpoints: correct segmentations and visualizations

Bench

sample size not stated

endpoints: meets specifications and requirements; ability to automatically create a pan curve to fit the arch; register (superimpose) the IOS over the CT; generate the X-Guide SurfiX

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recalls attributed to this device

  • Recalling firm matches this device's applicant (X-NAV Technologies, LLC) — same firm and product code, not necessarily this device · initiated 2024-03-04

    The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.

    recall event 94175 (openFDA)

  • Recalling firm matches this device's applicant (X-NAV Technologies, LLC) — same firm and product code, not necessarily this device · initiated 2024-03-04

    The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.

    recall event 94175 (openFDA)

  • Recalling firm matches this device's applicant (X-NAV Technologies, LLC) — same firm and product code, not necessarily this device · initiated 2022-09-28

    Product missing one of two welds connecting the tip to the shaft, if the remaining weld breaks, it is possible that the tip could fall out during X-Mark registration and fall into the patient s mouth. In this case, the patient may aspirate or swallow the probe tip.

    recall event 91067 (openFDA)

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Dental panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K232148