AI-Rad Companion Organs RT

K232899

Siemens Medical Solutions U.S.A. · cleared 2024-04-03 · 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 and MR predefined structures using deep-leaming-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 and MR predefined structures using deep-leaming-based algorithms.”
Adaptive (vs locked)No
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.”
PCCPFDA source did not state this
Cybersecurity addressedYes
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

Retrospective clinical

n=414 cases

endpoints: Dice coefficients; lower 95th percentile confidence bound

Reported performance (10 observations)

diceas written: “Dice [%]”85.75CI [82.85, 87.58]
source quote (p.14)
“85.75 6.48 [82.85, 87.58]”
diceas written: “AI-Rad Companion Organs RT VA50 – all organs Dice % Average”86CI (83-88)
source quote (p.14)
“AI-Rad Companion Organs RT VA50 – all organs 86 (83-88)”
diceas written: “AI-Rad Companion Organs RT VA50 – common organs Dice % Average”82CI (78-84)
source quote (p.14)
“AI-Rad Companion Organs RT VA50 – common organs 82 (78-84)”
diceas written: “MRCAT Pelvis (K182888) – all organs Dice % Average”77CI (75-79)
source quote (p.14)
“MRCAT Pelvis (K182888) – all organs 77 (75-79)”
diceas written: “Head & Neck Dice (%)”76.5CI [70.9, 80.8]
source quote (p.16)
“Head & Neck 76.5 12.8 [70.9, 80.8]”
diceas written: “Head & Neck lymph nodes Dice (%)”69.2CI [65.7.72.5]
source quote (p.16)
“Head & Neck lymph nodes 69.2 9.5 [65.7.72.5]”
diceas written: “Thorax Dice (%)”82.1CI [79.6, 83.9]
source quote (p.16)
“Thorax 82.1 8.4 [79.6, 83.9]”
diceas written: “Abdomen Dice (%)”88.3CI [80.9, 92.2]
source quote (p.16)
“Abdomen 88.3 8.3 [80.9, 92.2]”
diceas written: “Pelvis Dice (%)”84CI [80.7, 86.7]
source quote (p.17)
“Pelvis 84.0 6.5 [80.7, 86.7]”
diceas written: “Duodenum Dice (%)”77.3CI [74.5, 79.3]
source quote (p.17)
“Duodenum 76 77.3 10.4 79.7 [74.5, 79.3]”

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/K232899