K252548

The AI-Rad Companion Organs RT is radiation-therapy planning software that applies AI-based organ segmentation to CT imaging — contouring structures like organs-at-risk for dose planning. Product code QKB covers radiological image processing software broadly; the "Organs RT" naming signals this is targeted at radiation oncology workflows rather than diagnostic reading.

Radiology panel, Traditional 510(k). Siemens Healthineers has expanded the AI-Rad Companion family steadily since the initial clearance — each organ set or modality tends to get its own 510(k), which is why you see repeated QKB filings from the same applicant.

Siemens Healthcare GmbH files from Erlangen, Germany. Eight-month review clock. AI-assisted contouring has been a reliably-cleared category on QKB where the workflow is well-scoped.