uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis

Evidence summary

K243617 reports CT system, reconstruction, dual-energy, dose, image-quality, and software verification and validation for the named configurations. Lung screening is limited to labeled programs and protocols; the FDA summary does not establish a standalone AI diagnostic-performance claim.

FDA source Exact FDA submission Checked 2026-09-03

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No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

Postmarket safety review

1 exact-submission FDA recall record in the 2026-09-02 openFDA snapshot identify K243617. Affected model, version, unit, correction, and current manufacturer instructions still require local confirmation. FDA recall Z-0221-2026 is Open, Classified for Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only. FDA reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. FDA action: On September 12, 2025, UIH Technologies LLC, issued a recall notification to affected consignees. UIH asked consignees to take the following actions: 1. Ensure patient positioning clearance: When positioning the patient, confirm that arms and legs and clear of all table gaps and moving parts. 2. Avoid use of third-party slickers: We advise against the use of any non-UIH-approved slickers. 3. Service Contact: For technical assistance, contact your United Imaging Service engineer or reach out to our 24/7 Customer Contact Center, Toll-Free: (855) 221-1552/Direct: (832) 699-2799 4.Report adverse events: if any adverse events or quality issue occur, please report them to the FDA via the MedWatch program. 5. Please share this information with all relevant personnel at your facility, including technologist, service staff, and clinical teams.

FDA source Exact FDA submission Checked 2026-09-04

Each published event was manually matched to the exact FDA submission and affected product or version; a recall does not establish an AI-algorithm defect or current site exposure unless the event states that scope.

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• Verify security and privacy controls: 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.
• Verify pricing and total cost: 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.

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA decision materials were reviewed for identity, indication, users, workflow, limitations, and submitted performance. Current vendor material is labeled product-family context where it does not establish the exact release. PubMed and ClinicalTrials.gov results are retained as candidate evidence with version applicability pending; CMS reimbursement context and exact-identifier openFDA postmarket results were also checked. Pricing, final security architecture, contracted services, enabled options, and local interoperability remain organization-specific evidence. 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. 1 FDA recall candidate was manually reviewed: 1 published and 0 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 1 postmarket candidate record; 1 has been reviewed (1 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

• K243617 FDA decision source U.S. Food and Drug Administration · 2026-08-31
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• FDA recall Z-0221-2026: Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only U.S. Food and Drug Administration · 2026-09-04
• PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
• ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
• Medicare Coverage Database Centers for Medicare & Medicaid Services · 2026-09-01
• openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
• United Imaging uCT ATLAS United Imaging · 2026-09-03