Siemens Healthineers AI-Rad Companion

What is AI-Rad Companion and who sells it?

It is a set of AI extensions delivered through Siemens Healthineers' teamplay digital health platform. The vendor page lists five groups: Chest CT, Chest X-ray, Brain MR, Prostate MR and Organs RT. Chest CT also reports coronary calcium and heart volume, and the separately cleared Cardiovascular module is listed under K183268 below.

Siemens Healthineers AG is based in Erlangen, Germany. FDA records list Siemens Healthcare GmbH and Siemens Medical Solutions USA in Malvern, Pennsylvania. Siemens Healthineers completed its acquisition of Varian, the radiotherapy company, in April 2021 for about USD 16.4 billion, and Varian is now a Siemens Healthineers subsidiary.

What does each module do?

According to the vendor page, Chest CT detects lung nodules and reports volume and diameter, and also measures the aorta, spine, coronary calcium, heart volume and pulmonary density. Chest X-ray flags lung lesions, pneumothorax, consolidation and atelectasis. Brain MR does volumetric analysis against a normative database. Prostate MR segments the gland, reports volume and PSA density, and detects and classifies lesions. Organs RT contours organs at risk with deep learning, though male-pelvis MR contouring is not commercially available.

Results reach the reader through DICOM structured reports, PACS delivery and reporting templates, and Organs RT exports RTSS files. EHR integration, HIPAA, SOC 2 and HITRUST status are not stated on the vendor page. Siemens notes that AI-Rad Companion "is not commercially available in all countries."

What regulatory clearances exist?

The FDA database lists these 510(k) decisions:

• K183272, the Engine, February 2019
• K183271, Pulmonary, July 2019
• K183268, Cardiovascular, September 2019, updated under K222360 in April 2023
• K222361, Musculoskeletal, October 2022
• K193283, Prostate MR, July 2020, with a later K252608 in September 2025
• K193290, Brain MR, June 2020, with K213706 in April 2022
• K193562, Organs RT, November 2020, updated three times, most recently K252548 in April 2026

Chest X-ray has no FDA clearance, and the vendor says it is not for sale in the US. Siemens announced CE marking for Chest CT in July 2019 and describes Brain MR as CE marked. Current certificates under the EU Medical Device Regulation are not stated.

What does the evidence say?

Published studies on the chest modules include a 2021 BMC Medicine study of 117 low-dose CT patients, which found coronary calcium scoring agreement with kappa 0.846, and per-patient nodule detection with sensitivity 1 and specificity 0.708. In that sample no patient with a nodule was missed, and about three in ten patients without one were flagged. A repeatability study in the NELSON trial population, in European Radiology, found good to excellent consistency. For chest X-ray, a 2023 Scientific Reports study found sensitivity 0.83 against 0.52 for the original report, with more false detections.

No peer-reviewed evidence for the prostate or brain modules is cited in the vendor material.

How much does it cost?

Siemens licenses AI-Rad Companion at enterprise level, with no per-study price published. OEM bundling with Siemens scanners is the other route.

The verdict

For a Siemens shop, the cleared chest CT and prostate MR modules are the practical start, and the nodule false-positive rate in the 117-patient study is the number to test locally before rollout. A vendor-neutral department reading in Europe has a gap to close first, because current EU MDR certificates are not published. A US group wanting chest X-ray AI cannot buy this module and should plan around another vendor.