AiORTA - Plan v2.0

Evidence summary

The exact FDA submission K254207 is the identity anchor. Its public decision material supports the submission-specific product and intended-use summary recorded here; it does not establish a general product-wide sensitivity or specificity value for this dossier.

FDA source Exact FDA submission Checked 2026-09-04

• Source

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

Postmarket safety review

Not established in reviewed sources

Reviewed sources checked Exact FDA submission Checked 2026-09-04

No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

• Verify DICOM, HL7/FHIR, PACS/RIS/EHR integration: Exact submission evidence and the current vendor family material do not establish the exact site's DICOM, worklist, PACS/RIS, identity, routing, display, or fallback behavior.
• Verify deployment and data flow: Exact deployment topology, hosting, network boundaries, update mechanism, and local operational requirements are not established for this submission.
• Verify security and privacy controls: Public sources reviewed here do not establish the complete exact-release security posture, including identity, audit, encryption, retention, remote access, vulnerability management, backup, or incident response.
• Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
• Verify pricing and total cost: No public exact-release price, license fee, subscription, contract, or implementation cost was established in this review.
• Verify reimbursement and coding relevance: CMS index context was checked, but no product-specific coverage or reimbursement determination is inferred.
• 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.
• Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

This submission was added after the prior exact-submission extraction and remains queued for source review. Exact FDA identity, indication, modality, anatomy, workflow, and limitations were reviewed using the submission as the identity anchor. Current vendor material is product-family context only. PubMed and ClinicalTrials.gov candidates remain quarantined as product-family evidence because exact submission and version linkage was not established. CMS and openFDA index context was checked. Pricing, security, deployment, reimbursement, contracted services, enabled options, and local interoperability remain unknown unless separately evidenced. 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 0 postmarket candidate records; 0 have 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, vendor product page, implementation documentation, reimbursement policy, peer reviewed literature, clinical trial registry, fda device recall, pubmed, clinical trials, openfda device recall

• FDA decision summary for K254207 - AiORTA - Plan v2.0 U.S. Food and Drug Administration · 2026-09-04
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• 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
• Radiation Oncology Model Centers for Medicare & Medicaid Services · 2026-09-02
• ViTAA AiORTA family context ViTAA Medical Solutions · 2026-09-04