Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Iterative Scopes with 4 510(k) clearances and 4 AI-enabled devices. The most recent is a 510(k) clearance dated Jul 3, 2024: SKOUT® system.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jul 3, 2024 | SKOUT® systemK241508 · QNP | 510(k) clearances |
| Jul 3, 2024 | SKOUT® systemK241508 · Gastroenterology-Urology | AI-enabled devices |
| Apr 19, 2024 | SKOUT® systemK240781 · QNP | 510(k) clearances |
| Apr 19, 2024 | SKOUT® systemK240781 · Gastroenterology-Urology | AI-enabled devices |
| Apr 7, 2023 | SKOUT® systemK230658 · QNP | 510(k) clearances |
| Apr 7, 2023 | SKOUT® systemK230658 · Gastroenterology-Urology | AI-enabled devices |
| Aug 12, 2022 | SKOUT SoftwareK213686 · QNP | 510(k) clearances |
| Aug 12, 2022 | SKOUT SoftwareK213686 · Gastroenterology-Urology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
