AI-Rad Companion Organs RT
K242745Siemens Healthcare GmbH · cleared 2025-03-27 · product code QKB · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“Al-Rad Companion Organs RT is a post-processing software intended to automatically contour DICOM CT and MR pre-defined structures using deep-learning-based algorithms.”
source quote (p.4)
“Al-Rad Companion Organs RT is a post-processing software intended to automatically contour DICOM CT and MR pre-defined structures using deep-learning-based algorithms.”
source quote (p.8)
“All models contained within AI-Rad Companion Organs RT VA60 and AI-Rad Companion Organs RT VA50 (K232899) are locked and cannot be modified by the user.”
source quote (p.12)
“Siemens Healthineers adheres to the cybersecurity recommendations as defined the FDA Guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (September 2023) by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient.”
Validation studies (1)
Retrospective clinical
n=579 cases
endpoints: DICE coefficient; absolute symmetric surface distance (ASSD); fail rate
standards: 62366-1 Ed 1.1 2020-06 CV, 14971:2019-12, 62304 Ed 1.1 2015-06 CV, PS 3.1-3.20 2023e, 15223-1 Fourth edition 2021-07, 82304-1 Edition 1.0 2016-10, 81001-5-1 Edition 1.0 2021-12, 20417 First edition 2021-04
Reported performance (2 observations)
source quote (p.10)
“To objectively evaluate the target performance, the DICE coefficient, the absolute symmetric surface distance (ASSD) and the fail rate was evaluated.”
source quote (p.14)
“Head & Neck 76.1 14.3 [75.1, 77.2]”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).