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. The software runs on standard “off-the-shelf” hardware and can be used for image viewing and processing.”
AlgorithmImage processing software package with a trained algorithm for viewing, processing, and manipulation functions to visualize large vessels from head and neck CTA imaging.
source quote (p.4)
“CerebralGo Plus is a medical image management and processing software package to be used by trained professionals, including, but not limited to physicians and medical technicians. CerebralGo Plus system provides a wide range of basic image viewing, processing, and manipulation functions, through multiple output formats. The software is used to visualize large vessels from head and neck CTA imaging. Algorithm training of CerebralGo Plus has been conducted on images collected from China as training dataset.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Standalone

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

0
recalls in product code, 24mo
3
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/K213986