CT 5300

Evidence summary

K232491 describes manufacturer electrical, radiation, image-quality, dose, software, and system validation. Current vendor phantom claims provide evaluation inputs but should retain their reconstruction, dose, and object-size conditions.

Public 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

2 reviewed FDA recall records in the 2026-09-02 openFDA snapshot natively identify K232491. Read the model- and version-scoped events and confirm affected-unit and correction status with the manufacturer. FDA recall Z-0376-2026 affects CT 5300 software 5.1.0.X and 5.1.1.X and describes six motion, dose-setting, ECG-file, orientation, preview-display, and manual-ROI issues that could produce unusable imaging, additional exposure, or rescanning. FDA lists the recall as open and classified. FDA recall Z-0882-2026 affects CT 5300 software versions 4.5, 5.0, and 5.1 because improperly tightened heat-exchanger screws after replacement could allow a component to detach inside the rotating scanner. FDA lists the recall as open and classified.

FDA source Exact product version 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 batch do not establish the complete security posture for the exact release. Request data-flow, identity, audit, encryption, retention, support-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, enabled features, 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 materials, current product-family sources, selected clinical literature, reimbursement context, and exact-identifier recall candidates were reviewed. Pricing, contracted services, enabled options, final security architecture, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 0 PubMed and 5 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. 5 FDA recall candidates were manually reviewed: 2 published and 3 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 5 postmarket candidate records; 5 have been reviewed (2 published, 3 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, vendor product page, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall

• K232491 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-0376-2026: Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X; U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-0882-2026: CT 5300; Software Version Number: 4.5, 5.0, 5.1; 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
• CT 5300 product overview Philips · 2026-09-03