AI-Rad Companion Organs RT

K242745

Siemens Healthcare GmbH · cleared 2025-03-27 · product code QKB · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“AI-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.”
Algorithmdeep-learning-based algorithms
source quote (p.4)
“AI-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.”
Adaptive (vs locked)No
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.”
PCCPFDA source did not state this
Cybersecurity addressedYes
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 patients · 20 site(s)

endpoints: Dice coefficients; ASSD (Average Symmetric Surface Distance)

standards: ISO 14971:2019

Reported performance (6 observations)

diceas written: “Dice Coefficient (Head & Neck)”76.1CI [75.1, 77.2]
source quote (p.14)
“Head & Neck 76.1 14.3 [75.1, 77.2]”
diceas written: “Dice Coefficient (Head & Neck lymph nodes)”69.3CI [68.7, 70.0]
source quote (p.14)
“Head & Neck lymph nodes 69.3 13.9 [68.7, 70.0]”
diceas written: “Dice Coefficient (Thorax)”76.9CI [76.2, 77.6]
source quote (p.14)
“Thorax 76.9 15.8 [76.2, 77.6]”
diceas written: “Dice Coefficient (Abdomen)”87.3CI [86.3, 88.2]
source quote (p.14)
“Abdomen 87.3 10.1 [86.3, 88.2]”
diceas written: “Dice Coefficient (Pelvis)”85.7CI [85.0, 86.5]
source quote (p.14)
“Pelvis 85.7 9.6 [85.0, 86.5]”
diceas written: “Dice Coefficient (Cardiac)”75.6CI [74.1, 77.1]
source quote (p.14)
“Cardiac 75.6 15.1 [74.1, 77.1]”

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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K242745