FDA applicant
Magentiq Eye, Ltd.
FDA records 4 decisions for Magentiq Eye, Ltd. (Haifa, IL) from 2023 to 2026: 4 510(k) clearances. All are in product code QNP (Gastrointesinal Lesion Software Detection System). Since 2016 its 510(k)s took a median of 57 days from receipt to decision, against 84 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 3 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Magentiq Eye, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Magentiq Eye, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report