AI-Rad Companion Organs RT
K232899Siemens Medical Solutions U.S.A. · cleared 2024-04-03 · product code QKB · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“AI-Rad Companion Organs RT is a post-processing software intended to automatically contour DICOM CT and MR predefined structures using deep-leaming-based algorithms.”
source quote (p.7)
“AI-Rad Companion Organs RT VA50 and AI-Rad Companion Organs RT VA40 both use a deep learning algorithm to support their AI claims.”
source quote (p.7)
“All models contained within AI-Rad Companion Organs RT VA50 and AI-Rad Companion Organs RT VA40 (K221305) are locked and cannot be modified by the user.”
source quote (p.13)
“Siemens Healthineers adheres to the cybersecurity recommendations as defined the FDA Guidance "Content of Premarket Submissions for Management for Cybersecurity in Medical Devices,” issued October 2, 2014 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 (2)
Retrospective clinical
n=66 cases
endpoints: dice coefficient; absolute symmetric surface distance (ASSD); failure rate
standards: ISO 14971:2019
Retrospective clinical
n=414 cases · 32 site(s)
endpoints: mean and standard deviation Dice coefficients; lower 95th percentile confidence bound
standards: ISO 14971:2019
Reported performance (3 observations)
source quote (p.14)
“85.75 6.48 [82.85, 87.58]”
source quote (p.16)
“Head & Neck 76.5 12.8 [70.9, 80.8]”
source quote (p.17)
“Pelvis 84.0 6.5 [80.7, 86.7]”
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).