OEC One CFD

K253269

Ge Hualun Medical Systems Co. , Ltd. · cleared 2025-11-26 · product code OXO · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“The OEC One CFD is a mobile C-arm X-ray system to provide fluoroscopic images of the patient during diagnostic, interventional, and surgical procedures such as orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures. The primary change for the subject device is to introduce the optional Image Stitching and Deep learning-based Trajectory Pointer software features.”
Algorithmdeep learning technology to segment the Kirschner-wire then utilize a traditional algorithm to present a visual guideline
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.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.15)
“Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, June 27, 2025”

Validation studies (4)

Retrospective clinical

n=307 images

endpoints: success rate; Dice score

Bench

sample size not stated

endpoints: satisfactory quality for visual extended guideline

Bench

sample size not stated

endpoints: satisfactory quality for stitched images

Bench

sample size not stated

endpoints: quality images; performance claims related to dose and image quality

Reported performance (1 observation)

diceas written: “Dice score”0.9
source quote (p.17)
“At least 95% of test dataset should have a Dice score above 0.9.”

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

6
recalls in product code, 24mo
70
MAUDE reports in code, 12mo
-70%
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 (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · initiated 2025-03-21

    OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.

    recall event 96902 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · initiated 2025-03-21

    OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.

    recall event 96902 (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 Radiology 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/K253269