MAGENTIQ-COLO (ME-APDS)— 510(k) K260724
Substantially EquivalentMagentiq Eye, Ltd.
FDA 510(k) clearance K260724 for MAGENTIQ-COLO (ME-APDS), Substantially Equivalent on 2026-04-03. Applicant: Magentiq Eye, Ltd.. Device class: 2.
Summary
Magentiq Eye's MAGENTIQ-COLO (ME-APDS) is filed under product code QNP (Gastrointesinal Lesion Software Detection System), with the code name spelled that way in the record. The record doesn't describe the software beyond its name and that code name.
Class II, 21 CFR 876.1520. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Special 510(k).
Magentiq Eye filed from Haifa, Israel. The decision came 29 calendar days after FDA received it (March 5 to April 3, 2026).
Clearance details
- Applicant
- Magentiq Eye, Ltd.
- Product code
- Product code QNP
- Device class
- Class 2
- Regulation
- 21 CFR 876.1520
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Haifa, IL
Recent devices under product code QNP
view allMore clearances from Magentiq Eye, Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.