K250151
- 510(k) number
- K250151
- Device name
- Us2.ca
- Applicant
- Eko.Ai Pte Ltd. D/B/A Us2.Ai SG
- Product code
- SDJ — Adjunctive Cardiac Amyloidosis Status Indicator
- Decision date
- 2025-06-20
- Date received
- 2025-01-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K250151.pdf
Official FDA record: K250151
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.