Cardiovascular · 510(k) · 2024
EchoGo Amyloidosis (1.0)
Ultromics Limited. Cleared by FDA on 15 November 2024 under submission K240860, product code SDJ (adjunctive cardiac amyloidosis status indicator). What FDA's record says, in FDA's words.
Device record · K240860
- Device. EchoGo Amyloidosis (1.0)DEVICE
- Company. Ultromics Limited (GB)COMPANY
- Decision. 15 November 2024, 510(k), substantially equivalent (traditional review); received 28 March 2024DECISION
- Panel. CardiovascularPANEL
- Product code. SDJ, Adjunctive Cardiac Amyloidosis Status IndicatorCODE
- Regulation. 21 CFR 870.2200, Class IIREG
- Source. FDA database entry · decision document (27 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.
EchoGo Amyloidosis 1.0 is an automated machine learning-based decision support system, indicated as a screening tool for adult patients aged 65 years and over with heart failure undergoing cardiovascular assessment using echocardiography. When utilised by an interpreting physician, this device provides information alerting the physician for referral to confirmatory investigations. EchoGo Amyloidosis 1.0 is indicated in adult patients aged 65 years and over with heart failure. Patient management decisions should not be made solely on the results of the EchoGo Amyloidosis
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
- 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 Ultromics Limited, or cleared in 2024. The whole record is at FDA AI-enabled medical devices.
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