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.”
AlgorithmDeep learning contouring; artificial intelligence (AI) including non-adaptive machine learning algorithms
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. Software implementing artificial intelligence (AI) including non-adaptive machine learning algorithms trained with clinical and/or artificial radiological images.”
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.”
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

endpoints: automated 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.7)
“Segmentation Performance Test Evaluated automated segmentation accuracy non-inferiority 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

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/K203610