FDA-cleared profile
Shanghai United Imaging Healthcare Co., Ltd.
uDR Aurora CX acquires two-dimensional X-ray images of the labeled skull, spine, chest, abdomen, extremities, limbs, and trunk for review by qualified healthcare professionals; it is not a mammography system.
Clinical fit
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
Current vendor material is product-family context for K251167; confirm exact cleared version, enabled options, deployment, and local compatibility.
Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K251167 before acceptance.
exact submission · checked 2026-09-04Later product-family features are not evidence that this cleared release includes them.
Exact public integration details remain incomplete; establish and test the supported input, output, identity, routing, archive, and downtime contract locally.
product family · checked 2026-09-04Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally. Current vendor material is product-family context; confirm exact release, enabled options, deployment, and local compatibility.
Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. Use only the cleared anatomy, detector, projection, patient-size, dose, and positioning limits; the system is not a mammography substitute unless explicitly labeled for that use.
exact submission · checked 2026-09-04Define stop-use, escalation, rollback, and revalidation triggers before production use.
Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.
product family · checked 2026-09-04No exact-product price was found in the reviewed public material; productivity or value claims require local evidence.
Monitor by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: Use only the cleared anatomy, detector, projection, patient-size, dose, and positioning limits; the system is not a mammography substitute unless explicitly labeled for that use.
product family · checked 2026-09-04Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. Current vendor material is product-family context; confirm exact release, enabled options, deployment, and local compatibility.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Sensitivity is not a product-wide endpoint for this system or software function. Compare only an exact endpoint, threshold, population, version, and source if one is later verified.
Specificity is not a product-wide endpoint for this system or software function. Compare only an exact endpoint, threshold, population, version, and source if one is later verified.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
FDA substantial-equivalence decision with X-ray hardware, detector, image-quality, dose, safety, EMC, DICOM, and usability verification · Adult and pediatric radiographic examinations of the labeled skull, spine, chest, abdomen, extremities, limbs, and trunk
exact submission · Tested version: uDR Aurora CX configuration described in K251167 · Sponsor or vendor studyK251167
Manufacturer evidence submitted for the exact FDA decision. It is not independent clinical validation, and local technical, clinical, privacy, security, and workflow acceptance remains necessary.
Economics and lifecycle
These are common procurement questions; unknown values remain visible until a source supports them.
No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesBuild a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Exact-identifier review does not prove absence of all product-family safety signals.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact-name and exact-submission searches in the checked 2026-09-01 indexes returned no PubMed records and no ClinicalTrials.gov records for K251167; review status is candidate_review_pending. Any candidate literature or registry record remains quarantined as product-family evidence unless exact submission and version linkage is established. Current vendor material is product-family context. Pricing, complete security architecture, contracted deployment, exact reimbursement, and local interoperability remain unverified. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads remain unpublished until a human confirms the exact product and tested version.
Source classes: fda ai list, fda decision summary, fda decision material, vendor product page, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-04.
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