MR Contour DL

K242925

GE HealthCare · cleared 2025-04-01 · product code QKB · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.6)

“MR Contour DL is a post processing application intended to assist a clinician by generating contours of organ at risk (OAR) from MR images in the form of a DICOM Radiotherapy Structure Set (RTSS) series.”

Algorithmdeep learning segmentation algorithms

source quote (p.6)

“MR Contour DL uses deep learning segmentation algorithms that have been designed and trained specifically for the task of generating organ at risk contours from MR images.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

n=105 cases

endpoints: DICE score; HD95 metric

standards: 21CFR 820, ISO 13485

Reader study (MRMC)

n=70 cases

endpoints: Mean Likert Score

Reported performance (1 observation)

diceas written: “Mean DSC accuracy (incorporating all 37 organs)”81.1

source quote (p.12)

“The mean DSC accuracy (incorporating all 37 organs) was 81.1% for all, 81.3% for male, 83.4% for female, 82.7% for USA, 80.4% for Europe, 81.6% for patient, and 80.5% for healthy cases, which demonstrate the overall model performance was similar in all sub-cohorts.”

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).