uCT 780

Evidence summary

FDA-reviewed manufacturer evidence includes phantom testing and a 60-subject, two-reader clinical image-quality program with separated training, validation, and test data. The reported acceptance criteria were met, but FDA explicitly limits promotional interpretation and the evidence does not establish patient outcomes.

FDA source Exact FDA submission Checked 2026-09-02

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Postmarket safety review

FDA recall Z-0220-2026 affects uCT 780 systems. A third-party outer cover could become trapped between the patient table and gantry and interfere with table movement. FDA lists the recall as open and classified.

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: FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
• Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
• Verify pricing and total cost: FDA submission materials do not establish current commercial pricing. Request the pricing unit, term, minimum commitment, implementation fees, and included support from the vendor.
• Verify reimbursement and coding relevance: Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
• Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. The exact FDA summary, exact-identifier recall, and current product-family page were manually reviewed. Recall Z-0220-2026 concerns a third-party outer cover trapped between the table and gantry and is treated as a mechanical or accessory-use issue, not an AI defect. Patient outcomes, local interfaces, cybersecurity, staffing, training, service terms, price, total cost, and reimbursement remain separate verification tasks. Automated exact-name discovery found 1 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 device recall, vendor product page, pubmed, clinical trials, openfda device recall

• K241079 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-0220-2026: Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 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
• openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
• uCT 780 product-family page United Imaging Healthcare · 2026-09-02