OEC One CFD
K253269Ge Hualun Medical Systems Co. , Ltd. · cleared 2025-11-26 · product code OXO · Radiology
Premarket evidence — what FDA accepted
source quote (p.7)
“The primary change for the subject device is to introduce the optional Image Stitching and Deep learning-based Trajectory Pointer software features.”
source quote (p.14)
“Trajectory Pointer is a feature utilizing deep learning technology to segment the Kirschner-wire then utilize a traditional algorithm to present a visual guideline to aid in positioning Kirschner-wires or similar straight, solid metallic devices.”
source quote (p.16)
“Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, June 27, 2025”
Validation studies (1)
Standalone
n=307 images
endpoints: Dice score above 0.9; success rate
standards: IEC 60601-1, ANSI AAMI IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-54, IEC 60601-2-43, IEC 62304, IEC 62366-1, NEMA XR-27
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
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). 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).