SKOUT system

K251126

Iterative Health · cleared 2025-05-09 · product code QNP · Gastroenterology-Urology

Premarket evidence — what FDA accepted

Device typesimd
source quote (p.1)
“The SKOUT® system is a software-based computer aided detection (CADe) system for the analysis of high-definition endoscopic video during colonoscopy procedures. The SKOUT® system is intended to aid gastroenterologists with the detection of potential colorectal polyps during colonoscopy by providing an informational visual aid on the endoscopic monitor using trained software that processes the endoscopic video in real time.”
Algorithmartificial intelligence-based algorithm
source quote (p.4)
“The SKOUT® system utilizes an artificial intelligence-based algorithm to perform the polyp detection function.”
Adaptive (vs locked)No
source quote (p.6)
“The inference algorithms have remained the same, therefore clinical performance remains unchanged from the clinical testing submitted in K213686.”
PCCPNo
Cybersecurity addressedYes
source quote (p.6)
“Routine software updates to address bugs, cybersecurity, and code optimization identified by software maintenance activities;”

Validation studies (4)

Bench

sample size not stated

endpoints: evaluation of true positives; false positives; polyp detection time

Bench

sample size not stated

standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-1-6

Bench

sample size not stated

endpoints: confirm the SKOUT® system software meets design requirements for its intended use

standards: General Principles of Software Validation, Guidance for Industry and FDA Staff

Bench

sample size not stated

endpoints: confirm the device meets the special controls in 21 CFR 876.1520 for pixel degradation and video delays

standards: 21 CFR 876.1520

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
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K253664 (decision 2025-12-22) from Iterative Health for a matching device line ("SKOUT system") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K253664

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/K251126