AutoContour Model RADAC V2

K220598

Radformation, Inc. · cleared 2022-08-24 · product code QKB · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
As with AutoContour RADAC, the AutoContour RADAC V2 device is software that uses DICOM-compliant image data (CT or MR) as input to (1) automatically contour various structures of interest for radiation therapy treatment planning using machine learning based contouring.
Algorithmmachine learning based contouring, deep-learning based structure models, CNN architecture
source quote (p.5)
The deep-learning based structure models are trained using imaging datasets consisting of anatomical organs of the head and neck, thorax, abdomen and pelvis for adult male and female patients.(2) allow the user to review and modify the resulting contours, and (3) generate DICOM-compliant structure set data the can be imported into a radiation therapy treatment planning system AutoContour RADAC V2 consists of 3 main components: 1. A.NET client application designed to run on the Windows Operating System allowing the user to load image and structure sets for upload to the cloud-based server for automatic contouring, perform registration with other image sets, as well as review, edit, and export the structure set. 2. A local "agent” service designed to run on the Windows Operating System that is configured by the user to monitor a network storage location for new CT and MR datasets that are to be automatically contoured. 3. A cloud-based automatic contouring service that produces initial contours based on image sets sent by the user from the .NET client application.
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (3)

Retrospective clinical

n=140 images

endpoints: Mean Dice Similarity Coefficient (DSC)

standards: NRG/RTOG guidelines

Retrospective clinical

n=50 patients

endpoints: Sensitivity; Specificity

standards: NRG/RTOG guidelines

Retrospective clinical

n=16 images · 1 site(s)

endpoints: Mean Dice Similarity Coefficient (DSC); Sensitivity; Specificity

standards: NRG/RTOG guidelines

Reported performance (4 observations)

diceas written: “Mean Dice Similarity Coefficient (DSC) for CT Large structures0.94CI +/-0.03
source quote (p.12)
For CT Large, Medium, and Small structures, AutoContour's results had a mean DSC of 0.94+/-0.03, 0.82+/-0.09, and 0.61+/-0.14 respectively
diceas written: “Mean Dice Similarity Coefficient (DSC) for CT Medium structures0.82CI +/-0.09
source quote (p.12)
For CT Large, Medium, and Small structures, AutoContour's results had a mean DSC of 0.94+/-0.03, 0.82+/-0.09, and 0.61+/-0.14 respectively
diceas written: “Mean Dice Similarity Coefficient (DSC) for CT Small structures0.61CI +/-0.14
source quote (p.12)
For CT Large, Medium, and Small structures, AutoContour's results had a mean DSC of 0.94+/-0.03, 0.82+/-0.09, and 0.61+/-0.14 respectively
diceas written: “Mean Dice Similarity Coefficient (DSC) for MR Structure models0.67CI +/-0.08
source quote (p.16)
For MR Structure models a mean DSC of 0.67+/-0.08 was found across all structure models.

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
3
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K260509 (decision 2026-03-19) from Radformation, Inc. for a matching device line ("AutoContour (RADAC V5)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K260509

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K242729 (decision 2024-12-09) from Radformation, Inc. for a matching device line ("AutoContour (Model RADAC V4)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K242729

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K230685 (decision 2023-04-14) from Radformation, Inc. for a matching device line ("AutoContour Model RADAC V3") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K230685

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).

RIGOR™ Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: radar.healthai.com/precedent/device/K220598