Us2.ca
FDA 510(k) clearance K250151 · decided 2025-06-20
Clearance details
- K-number
- K250151
- Device name
- Us2.ca
- Applicant
- Eko.Ai Pte Ltd. D/B/A Us2.Ai
- Decision
- Substantially Equivalent
- Date received
- 2025-01-21
- Decision date
- 2025-06-20
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- SDJ
- Device class
- 2
- Regulation number
- 870.2200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Singapore, SG
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| InVision Precision Cardiac Amyloid (K243866) | InVision Medical Technology Corporation | 2025-05-21 |
| EchoGo Amyloidosis (1.0) (K240860) | Ultromics Limited | 2024-11-15 |
Recalls involving this device
No recalls on record reference this clearance.