FDA applicant
Eko.Ai Pte Ltd. D/B/A Us2.Ai
FDA records 3 decisions for Eko.Ai Pte Ltd. D/B/A Us2.Ai (Singapore, SG) from 2021 to 2025: 3 510(k) clearances. Most are in product codes QIH (Automated Radiological Image Processing Software) and SDJ (Adjunctive Cardiac Amyloidosis Status Indicator). Its devices cite 3 predicates, 1 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 Eko.Ai Pte Ltd. D/B/A Us2.Ai’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Eko.Ai Pte Ltd. D/B/A Us2.Ai’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