EndoScreener

K211326

Chengdu Wision Medical Device Co., LTD. · cleared 2021-11-19 · product code QNP · Gastroenterology-Urology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“EndoScreener is intended as a stand-alone software for real-time automatic detection of polyps in colonoscopy video stream during the procedure.”
Algorithmartificial intelligence algorithms, customized deep learning model
source quote (p.5)
“Both the EndoScreener and the GI Genius use artificial intelligence algorithms to assist clinicians in detecting colon polyps colonoscopy examination. The subject device uses a customized deep learning model, which is likely to be slightly different from the deep learning model and customization used by GI Genius.”
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)

Retrospective clinical

n=1,138 patients

endpoints: per-image sensitivity; specificity; per-polyp sensitivity; AUC

Prospective clinical

n=223 patients · 4 site(s)

endpoints: adenoma miss rate (AMR); 1st pass adenoma per colonoscopy (APC)

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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 Gastroenterology-Urology 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/K211326