Automatic Anatomy Recognition (AAR)

K203610

Quantitative Radiology Solutions, LLC · cleared 2021-04-20 · product code QKB · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“Automatic Anatomy Recognition product for radiation therapy planning (AAR) is a software-only medical device and is deployed on a cloud-based platform. The predicate and subject device are both software-only medical devices.”

AlgorithmDeep Learning

source quote (p.5)

“The predicate and subject device both utilize deep learning contouring to automatically contour the organ-at-risk for the head, neck, and thorax.”

Adaptive (vs locked)No

source quote (p.5)

“Software implementing artificial intelligence (AI) including non-adaptive machine learning algorithms trained with clinical and/or artificial radiological images.”

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

endpoints: segmentation accuracy using DICE similarity coefficients; mean 95% Hausdorff Distance (HD) calculation

standards: IEC 62304

Reported performance (1 observation)

diceas written: “DICE similarity coefficients”stated without value

source quote (p.5)

“The predicate and subject device conducted segmentation performance tests to evaluate the automated segmentation accuracy using DICE similarity coefficients.”

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

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).