AI-Rad Companion Organs RT
K221305Siemens Medical Solutions USA, Inc · cleared 2022-10-14 · 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 imaging data using deep-learning-based algorithms.”
source quote (p.3)
“AI-Rad Companion Organs RT is a post-processing software intended to automatically contour DICOM CT imaging data using deep-learning-based algorithms.”
source quote (p.6)
“All models contained within AI-Rad Companion Organs RT VA40 and AI-Rad Companion Organs RT VA20 (K193562) 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 "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=113 cases · 7 site(s)
endpoints: DICE coefficient; absolute symmetric surface distance (ASSD); fail rate; lower 95th percentile confidence bound
Bench
sample size not stated
endpoints: performance claims; functionality of new features and software updates; testable requirements in the Requirement Specifications
standards: IEC 62366-1: 2015-02, ISO 14971:2007, AAMI ANSI IEC 62304: 2006/A1:2016, NEMA PS 3.1-3.20 (2016), ISO IEC 10918-1 1994-02-15, ISO IEC 15223-1 Fourth edition 2021-07, IEC 82304-1 Edition 1.0 2016-10
Reported performance (3 observations)
source quote (p.13)
“The subject device achieved a median DICE score of 0.85 with a median ASSD of 0.93 in comparison to the predicate device achieving a median DICE score of 0.85 with a median ASSD of 0.94 for existing organs.AI-Rad Companion Organs RT VA40 DICE Median 0.85 95% CI (Bootstrap) [80.23,84.61]”
source quote (p.14)
“AI-Rad Companion Organs RT VA40 (Head and Neck lymph node class) Dice [%] Avg 81.32 95% CI Bootstrap [80.32,82.12]”
source quote (p.14)
“Contour ProtégéAI from MIM Software Inc (Pelvic lymph node class) Dice [%] Avg 80 95% CI Bootstrap [77,N.A]”
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).