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
PCCPNo
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

n=105 cases

endpoints: DICE score; HD95 metric

standards: 21 CFR 820, ISO 13485

Reader study (MRMC)

n=70 cases

endpoints: Likert score

Reported performance (1 observation)

diceas written: “DSC MEAN (bladder)”92.4
source quote (p.13)
“bladder pelvis 53 80% 92.4% 4.7 Improved 40 3.7”

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/K242925