Radiology · 510(k) · 2025
OEC One CFD
Ge Hualun Medical Systems Co. , Ltd.. Cleared by FDA on 26 November 2025 under submission K253269, product code OXO (image-intensified fluoroscopic x-ray system, mobile). What FDA's record says, in FDA's words.
Device record · K253269
- Device. OEC One CFDDEVICE
- Company. Ge Hualun Medical Systems Co. , Ltd. (CN)COMPANY
- Decision. 26 November 2025, 510(k), substantially equivalent (traditional review); received 29 September 2025DECISION
- Panel. RadiologyPANEL
- Product code. OXO, Image-Intensified Fluoroscopic X-Ray System, MobileCODE
- Regulation. 21 CFR 892.1650, Class IIREG
- Source. FDA database entry · decision document (18 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The product is designed to provide fluoroscopic and digital spot images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures.
The product code's definition, from FDA's classification record. Fluoroscopy of the human body.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedendoscopy
- Mentionsa diagnostic claim
- Mentionsadult patients
- Mentionspediatric patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 10,999 reports filed against devices carrying product code OXO. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
25 September 2026 · Malfunction · Flourocsan InSight · Hologic, Inc · report 3005496266-2026-00272
17 September 2026 · Injury · O-Arm Imaging System · MEDTRONIC NAVIGATION, INC. (Boxborough) · report 3004785967-2026-00510
Citation: Soni, A., Vidyadhara, S., Vijayaraghavan, S. P., Balamurugan, T., Iyer, R. D., Krishnamoorthy, D., & Rao, S. K. (2026). The woodpecker variable-speed drilling protocol for robot-assisted subaxial cervical pedicle screw placement: Technique and a consecutive series of 1027 screws. Journal of Robotic Surgery, 20(1). https://doi.org/10.1007/s11701-026-03899-0 Abstract: Published descriptions of robot-assisted cervical pedicle screw placement remain limited, particularly for subaxial […]
8 September 2026 · Malfunction · O-Arm Imaging System · MEDTRONIC NAVIGATION, INC. (Boxborough) · report 3004785967-2026-00498
4 September 2026 · Malfunction · Orthoscan Versa Mini C-arm · Ziehm-Orthoscan, Inc. · report 3005254598-2026-00001
2 September 2026 · Other · OEC ELITE · report MW6001756
(b)(4) ( rep) called to report that during the scan they were unable to pass registration. Tey L3 to S1. Clamped on L3. Camera was at the patient's head. They could not register L3- They were doing CT to fluro registration- on the registration page L3 was red. She tried to register off of vertebra bodies, and it still did not register- it stayed red. Removed retractors they took new images. They adjusted the clamp so that it was not covering as much of the body. they kept it on L3- No […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code OXO, in Radiology, from Ge Hualun Medical Systems Co. , Ltd., or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.