Cardiovascular · 510(k) · 2025
Us2.ca
Eko.Ai Pte Ltd. D/B/A Us2.Ai. Cleared by FDA on 20 June 2025 under submission K250151, product code SDJ (adjunctive cardiac amyloidosis status indicator). What FDA's record says, in FDA's words.
Device record · K250151
- Device. Us2.caDEVICE
- Company. Eko.Ai Pte Ltd. D/B/A Us2.Ai (SG)COMPANY
- Decision. 20 June 2025, 510(k), substantially equivalent (traditional review); received 21 January 2025DECISION
- Panel. CardiovascularPANEL
- Product code. SDJ, Adjunctive Cardiac Amyloidosis Status IndicatorCODE
- Regulation. 21 CFR 870.2200, Class IIREG
- Source. FDA database entry · decision document (14 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
if it is known. This K250151Please type in the marketing application/submission number, textbox will be left blank for original applications/submissions. Please provide the device trade name(s). ? IUs2.ca Please provide your Indications for Use below. Us2.ca processes acquired transthoracic cardiac ultrasound images to support qualified cardiologists, sonographers, or other licensed professional healthcare practitioners in their diagnosis of cardiac amyloidosis. Us2.ca is intended for use only in adult patients with increased left ventricular wall thickness, defined as an interventricular septal thickness (IVSd) or left ventricular posterior wall thickness (LVPWd) > 12mm. Us2.ca is not intended to provide a diagnosis and does not replace current standards of care. The results from Us2.ca are not intended to exclude the need for further follow-up on cardiac amyloidosis. I
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedultrasound
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsa diagnostic claim
- Mentionsa statement that it is not for primary diagnosis
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code SDJ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code SDJ, in Cardiovascular, from Eko.Ai Pte Ltd. D/B/A Us2.Ai, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.