Us2.ca

510(k)K250151CardiovascularSDJ

Eko.Ai Pte Ltd. D/B/A Us2.Ai is listed for Us2.ca (K250151). The FDA list gives June 20, 2025 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code SDJ as “Adjunctive Cardiac Amyloidosis Status Indicator”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250151

Official FDA database record

Date of final decision: June 20, 2025
Company on the FDA list: Eko.Ai Pte Ltd. D/B/A Us2.Ai
Lead panel: Cardiovascular
Primary product code: SDJ
openFDA device name for the code: Adjunctive Cardiac Amyloidosis Status Indicator
Device class: 2
Regulation number: 870.2200
openFDA decision description: Substantially Equivalent
openFDA decision code: SESE
Statement or summary label: Summary

Product-code text from openFDA

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.