AI-Rad Companion Organs RT

K193562

Siemens Medical Solutions USA, Inc. · cleared 2020-11-06 · product code QKB · Radiology

Premarket evidence — what FDA accepted

Device typesamd

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.”

Algorithmdeep-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.”

Adaptive (vs locked)FDA source did not state this

PCCPNo

Cybersecurity addressedYes

source quote (p.12)

“Siemens Healthineers adheres to the cybersecurity requirements 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 (1)

Retrospective clinical

n=113 cases

endpoints: DICE coefficient; absolute symmetric surface distance (ASSD); fail rate; 95% Hausdorff (HD) value

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

Reported performance (2 observations)

diceas written: “DICE”0.85

source quote (p.12)

“AI-Rad Companion Organs RT MED: 0.85”

diceas written: “DICE (AccuContour)”stated without valueCI 0.85-0.95

source quote (p.12)

“AccuContour (K191928) 0.85-0.95”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K221305 (decision 2022-10-14) from Siemens Medical Solutions USA, Inc for a matching device line ("AI-Rad Companion Organs RT") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K221305

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).