Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5

Evidence summary

FDA-reviewed support consists of manufacturer verification and validation with phantoms and volunteer data. The summary reports no clinical study and no quantitative performance results for the V6.5 changes.

FDA source Exact FDA submission Checked 2026-09-02

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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

FDA recall Z-0198-2023 includes Canon Aplio a550, a450, and Aplio a systems. If a Stress Echo protocol is not manually terminated, a subsequent examination may fail to save images or may assign images to the previous patient, potentially delaying treatment. 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 candidate, and current Canon interoperability index were manually reviewed. Clinical outcomes, installed interface details, security, training, pricing, and reimbursement remain separate verification tasks. 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 device recall, vendor interoperability, pubmed, clinical trials, openfda device recall

• K212960 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-0198-2023: Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550 CUS-AA550, Aplio a450 CUS-AA450 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
• IHE integration statements for current Canon ultrasound products Canon Medical Systems Corporation · 2026-09-02