SKOUT® system

K230658

Iterative Scopes Inc. · cleared 2023-04-07 · product code QNP · Gastroenterology-Urology

Premarket evidence — what FDA accepted

Device typesimd
source quote (p.6)
“A gastrointestinal lesion software detection system is a computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in the detection of lesions. The device has hardware components to support interfacing with an endoscope.”
Algorithmartificial intelligence-based algorithm
source quote (p.7)
“The SKOUT system utilizes an artificial intelligence-based algorithm to perform the polyp detection function.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (4)

Bench

sample size not stated

Bench

sample size not stated

standards: IEC 60601-1:2005, AMD 1:2012, IEC 60601-1-2: 2014, IEC 60601-2-18: 2009

Bench

sample size not stated

Bench

sample size not stated

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
2
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K241508 (decision 2024-07-03) from Iterative Scopes, Inc. 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:K241508

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K240781 (decision 2024-04-19) from Iterative Scopes, Inc. 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:K240781

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/K230658