RT-Mind-AI

K213155

MedMind Technology Co., Ltd. · cleared 2021-12-15 · product code QKB · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“The proposed device, RT-Mind-AI, is a standalone software which used by radiation oncology department to segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation.”

AlgorithmDeep learning contouring

source quote (p.5)

“Deep learning contouring:”

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

sample size not stated

endpoints: DICE similarity coefficients (DSC); non-inferiority compared with that of the predicate device

Bench

sample size not stated

endpoints: DICE similarity coefficients (DSC); non-inferiority compared with that of other segment organs of proposed device

Reported performance (1 observation)

diceas written: “DICE similarity coefficients (DSC)”stated without value

source quote (p.6)

“DICE similarity coefficients (DSC) was used for evaluation.”

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).