K250151 is an FDA 510(k) clearance for the Us2.ca. This device is classified as a Adjunctive Cardiac Amyloidosis Status Indicator (Class II - Special Controls, product code SDJ).
Submitted by Eko.Ai Pte Ltd. D/B/A Us2.Ai (Singapore, SG). The FDA issued a Cleared decision on June 20, 2025, 150 days after receiving the submission on January 21, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2200. The Adjunctive Cardiac Amyloidosis Status Indicator Is A Prescription Device Based On Sensor Technology Or Image Data To Provide Information To An Interpreting Clinician In Detecting Cardiac Amyloidosis. This Device Is Intended For Adjunctive Use With Other Physical Vital Sign Parameters And Patient Information And Is Not Intended To Independently Direct Therapy..
| 510(k) Number | K250151 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2025 |
| Decision Date | June 20, 2025 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | SDJ - Adjunctive Cardiac Amyloidosis Status Indicator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2200 |
| Definition | The Adjunctive Cardiac Amyloidosis Status Indicator Is A Prescription Device Based On Sensor Technology Or Image Data To Provide Information To An Interpreting Clinician In Detecting Cardiac Amyloidosis. This Device Is Intended For Adjunctive Use With Other Physical Vital Sign Parameters And Patient Information And Is Not Intended To Independently Direct Therapy. |