510(k) K250151
K250151 is an FDA 510(k) premarket notification submitted by Eko.Ai Pte Ltd. D/B/A Us2.Ai for the device "Us2.ca". The FDA issued a decision of Substantially Equivalent on Jun 20, 2025. The device falls under product code SDJ (Adjunctive Cardiac Amyloidosis Status Indicator), a Class II device regulated under 21 CFR 870.2200. Eko.Ai Pte Ltd. D/B/A Us2.Ai has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 20, 2025
- Date Received
- Jan 21, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adjunctive Cardiac Amyloidosis Status Indicator
- Device Class
- Class II
- Regulation Number
- 870.2200
- Review Panel
- CV
- Submission Type
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.