CerebralGo Plus

K213986

Yukun (Beijing) Technology Co., Ltd · cleared 2023-04-13 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“CerebralGo Plus is an image processing software package to be used by trained professionals, including, but not limited to physicians and medical technicians.”

AlgorithmFDA source did not state this

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=141 images

endpoints: Dice coefficient; 95% Hausdorff Distance

standards: 21 CFR 820, DICOM standard

Reported performance (1 observation)

diceas written: “Dice coefficient”0.942

source quote (p.8)

“the value of Dice coefficient was 0.942”

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).