syngo.via RT Image Suite

Evidence summary

FDA summaries include release-specific software verification and clinical or nonclinical testing for automatic contouring, Synthetic CT, ventilation, and workflow changes. A vendor-collaborative VB40 clinical study reported substantial time savings but also requires exact-version, structure, and local-case-mix validation. Exact FDA recalls add important geometry, configuration, and structure-set completeness controls for VB40 and VB60.

Public source Exact FDA submission Checked 2026-09-03

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Postmarket safety review

2 reviewed FDA recall records in the 2026-09-02 openFDA snapshot natively identify K211379. Read each event for affected software, failure mode, corrective action, and current status; do not assume an installed build is affected or corrected without vendor confirmation. FDA recall Z-0994-2022 affected syngo.via RT Image Suite VB60 because an upgrade could automatically change markerless-workflow laser configuration settings, potentially displaying incorrect laser-offset coordinates during patient marking. FDA lists the recall as terminated. FDA recall Z-2445-2021 affected syngo.via RT Image Suite VB30 through VB60 because editing a structure set after saving and reopening a study could cause data loss and send an incomplete structure set to the treatment-planning system. FDA lists the recall as open and classified in the reviewed snapshot.

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: Public materials reviewed for this batch do not establish the complete security posture for the exact release. Request architecture, data flow, identity, audit, encryption, retention, support-access, vulnerability-management, and incident-response evidence.
• Verify pricing and total cost: No public list price for the exact cleared release was found. Obtain a written quote separating license basis, sites or users, enabled modules or models, implementation, interfaces, compute, storage, training, support, upgrades, renewal, and exit costs.

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA decision materials, current product-family materials, directly relevant clinical literature, reimbursement context, and exact-identifier recall candidates were reviewed. Pricing, final security architecture, contracted services, enabled modules or models, interoperability, and local acceptance remain organization-specific evidence. 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. 2 FDA recall candidates were manually reviewed: 2 published and 0 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 2 postmarket candidate records; 2 have been reviewed (2 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, peer reviewed publication, health technology guidance, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall

• K211379 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-0994-2022: syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade. U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-2445-2021: syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180 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
• Radiation Oncology Model Centers for Medicare & Medicaid Services · 2026-09-02
• Artificial intelligence technologies to aid contouring for radiotherapy treatment planning National Institute for Health and Care Excellence · 2026-09-02
• syngo.via RT Image Suite product page Siemens Healthineers · 2026-09-03
• Clinical validation of Siemens syngo.via automatic contouring Advances in Radiation Oncology · 2026-09-03