TAIMedImg DeepMets

K250427

Taiwan Medical Imaging Co., Ltd. · cleared 2025-05-28 · product code QKB · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“TAIMedImg DeepMets is a software device intended to assist trained medical professionals by providing initial object contours on axial T1-weighted contrast-enhanced (T1WI+C) brain magnetic resonance (MR) images to accelerate workflow for radiation therapy treatment planning.”
Algorithmdeep learning neural networks
source quote (p.6)
“The AI inference module consists of image preprocessing, deep learning neural networks, and postprocessing components, and is intended to contour brain metastasis on the axial T1-weighted contrast-enhanced (T1WI+C) MR images. It utilizes deep learning neural networks to generate contours and annotations for the diagnosed brain metastases.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=158 patients · 16 site(s)

endpoints: Lesion-Wise Sensitivity (Se); False Positive Rate (FPR); Dice Similarity Coefficient (DSC); Hausdorff Distance (HD); Centroid Distance (CD)

standards: IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes, ISO 14971: 2019 Medical devices - Applications of risk management to medical device

Reported performance (2 observations)

sensitivity89.97CI (86.51, 93.43)
source quote (p.9)
“Lesion-Wise Sensitivity (Se) (%) 89.97 (86.51, 93.43)”
diceas written: “Dice Similarity Coefficient (DSC)”0.7CI (0.67, 0.72)
source quote (p.9)
“Dice Similarity Coefficient (DSC) 0.70 (0.67, 0.72)”

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/K250427