Ge Hualun Medical Systems Co., Ltd. radiology AI products

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Radiology AI pricing and total cost of ownership

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FDA-cleared K253269

OEC One CFD

Ge Hualun Medical Systems Co., Ltd.

Authorized purpose: OEC One CFD provides fluoroscopic and digital-spot images for adult and pediatric diagnostic, interventional, surgical, orthopedic, gastrointestinal, urologic, neurologic, vascular, critical-care, and emergency procedures, with optional trajectory guidance.

Modality: Fluoroscopy/Angiography
Anatomy: Orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical-care, and emergency anatomy
Decision: 2025-11-26

Fluoroscopy/Angiography workflow

FDA-cleared K250788

Definium Tempo Select

GE Hualun Medical Systems Co., Ltd

Authorized purpose: Definium Tempo Select acquires, displays, and manages digital radiographic images of the skull, spine, chest, abdomen, extremities, and other labeled body parts for routine radiography across the labeled age range.

Modality: X-ray/Radiography
Anatomy: Skull; spinal column; chest; abdomen; extremities; and other routine radiography anatomy
Decision: 2025-08-28

MSK and bone