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. uAid evaluates the positioning quality of chest images with deep learning methods.”
AlgorithmDeep learning methods for evaluating image positioning quality and image characteristics, and patient positioning recognition technology using multi-modal real-time automatic localization, body modeling, and pose estimation.
source quote (p.15)
“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 (3)

Retrospective clinical

n=349 cases

endpoints: automatically set system position and field size will meet clinical technicians' criteria with 95% compliance

Retrospective clinical

n=6,552 patients · 2 site(s)

endpoints: accuracy of non-standard image recognition; 90% pass rate; sensitivity and specificity of whether there is a foreign body, whether the lung field is intact, and whether the scapula is open all exceed 0.9

Reader study (MRMC)

sample size not stated

endpoints: image quality is sufficient for clinical diagnosis

Reported performance (2 observations)

sensitivityas written: “Sensitivity for foreign body, lung field intact, scapula open”stated without valueCI >0.9
source quote (p.20)
“For uAid, the sensitivity and specificity of whether there is a foreign body, whether the lung field is intact, and whether the scapula is open all exceed 0.9;”
specificityas written: “Specificity for foreign body, lung field intact, scapula open”stated without valueCI >0.9
source quote (p.20)
“For uAid, the sensitivity and specificity of whether there is a foreign body, whether the lung field is intact, and whether the scapula is open all exceed 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

13
recalls in product code, 24mo
42
MAUDE reports in code, 12mo
+14%
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 (Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China) — same firm and product code, not necessarily this device · initiated 2021-01-25

    There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded motion. This could result in a collision with the patient.

    recall event 87289 (openFDA)

  • Recalling firm matches this device's applicant (Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China) — same firm and product code, not necessarily this device · initiated 2020-02-27

    Two issues were identified with the stationary x-ray system. 1. Some position illustrations in the patient exam interface show the incorrect anatomical position for the standard of care. When the image is acquired with the wrong reference position, clinical diagnostic requirements cannot be met.T2. Where image stitching is used, the left and right tag information may be lost. When these problems are encountered, an additional exposure is needed and the patient will receive more radiation.

    recall event 85196 (openFDA)

  • Recalling firm matches this device's applicant (Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China) — same firm and product code, not necessarily this device · initiated 2019-07-30

    X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be incorrectly labeled and may cause the patient to have a repeat exposure.

    recall event 90104 (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/K251167