uDR Aurora CX

K251167

Shanghai United Imaging Healthcare Co., Ltd. · cleared 2025-09-19 · product code KPR · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.6)

“uDR Aurora CX is a model of Digital Medical X-ray Imaging System developed and manufactured by Shanghai United Imaging Healthcare Co., Ltd(UIH). It includes X-ray Generator, X-ray Imaging System. The X-ray Generator produces controlled X-rays by high-voltage generator and X-ray tube assembly, ensuring stable energy output for human body penetration. The X-ray Imaging System converts X-ray photons into electrical signals by detectors, and generates DICOM-standard images by workstation to reflecting density variations of human body. The uVision algorithm in the digital medical X-ray imaging system (uDR Aurora CX) aims to optimize the radiographic scanning workflow through patient positioning recognition technology. This algorithm utilizes cameras to capture natural images of the human body, achieving multi-modal real-time automatic localization of key anatomical points, body modeling, and pose estimation for patients. It provides the system with scanning positions, ranges, and generates motion trajectory plans for DR racks. uAid evaluates the positioning quality of chest images with deep learning methods.”

AlgorithmThe uVision algorithm utilizes cameras to capture natural images of the human body, achieving multi-modal real-time automatic localization of key anatomical points, body modeling, and pose estimation for patients. uAid evaluates the positioning quality of chest images with deep learning methods.

source quote (p.16)

“The uVision algorithm in the digital medical X-ray imaging system (uDR Aurora CX) aims to optimize the radiographic scanning workflow through patient positioning recognition technology. This algorithm utilizes cameras to capture natural images of the human body, achieving multi-modal real-time automatic localization of key anatomical points, body modeling, and pose estimation for patients. It provides the system with scanning positions, ranges, and generates motion trajectory plans for DR racks. uAid evaluates the positioning quality of chest images with deep learning methods.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

n=348 cases

endpoints: meet clinical technicians' criteria with 95% compliance

Retrospective clinical

n=6,836 patients

endpoints: sensitivity and specificity of whether there is a foreign body; whether the lung field is intact; whether the scapula is open

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

+14%

vs code's own 3-yr baseline

drift signals on this device

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).