3mensio Workstation

Evidence summary

The FDA 510(k) summary reports non-clinical verification and validation but no independent clinical performance study or comparative clinical endpoint.

FDA source Exact FDA submission Checked 2026-08-31

• Source

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

Postmarket safety review

FDA Class II recall Z-2767-2026 covers 3mensio Workstation versions 10.7 through 10.7 SP5 under specified Philips 3D echocardiography Color Doppler conditions. The FDA record states the issue was resolved in version 10.7 SP6; the recall remains open and classified in the reviewed record.

FDA source Exact product version Checked 2026-09-02

• Source

• Verify care setting and population: Confirm the intended care setting, patient population, and service line.
• Verify limitations: Confirm contraindications, unsupported populations, scanners, protocols, and known failure modes.
• 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 decision summary and exact-submission recall record were manually reviewed. Commercial security, training, monitoring, 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. Native FDA recall identifiers produced 1 postmarket candidate record; 1 has 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 device recall, pubmed, clinical trials, openfda device recall

• K250330 FDA 510(k) decision summary U.S. Food and Drug Administration · 2026-09-02
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• FDA Class II recall Z-2767-2026 for 3mensio Workstation U.S. Food and Drug Administration · 2026-09-02
• 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