Cardiovascular · 510(k) · 2024
EchoGo Heart Failure (2.0)
Ultromics Limited. Cleared by FDA on 23 September 2024 under submission K240013, product code QUO (adjunctive heart failure status indicator). What FDA's record says, in FDA's words.
Device record · K240013
- Device. EchoGo Heart Failure (2.0)DEVICE
- Company. Ultromics Limited (GB)COMPANY
- Decision. 23 September 2024, 510(k), substantially equivalent (traditional review); received 2 January 2024DECISION
- Panel. CardiovascularPANEL
- Product code. QUO, Adjunctive Heart Failure Status IndicatorCODE
- Regulation. 21 CFR 870.2200, Class IIREG
- Source. FDA database entry · decision document (17 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 Heart Failure 2.0 is an automated machine learning-based decision support system, indicated as a diagnostic aid for patients undergoing routine functional cardiovascular assessment using echocardiography. When utilised by an interpreting clinician, this device provides information that may be useful in detecting heart failure with preserved ejection fraction (HFpEF). EchoGo Heart Failure 2.0 is indicated in adult populations over 25 years of age. Patient management decisions should not be made solely on the results of the EchoGo Heart Failure 2.0 analysis. EchoGo Heart Failure 2.0 takes as input an apical 4-chamber view of the heart that has been captured and assessed to have an ejection fraction 50%.
The product code's definition, from FDA's classification record. The adjunctive heart failure status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting heart failure. 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
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QUO. 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 QUO, in Cardiovascular, from Ultromics Limited, or cleared in 2024. The whole record is at FDA AI-enabled medical devices.
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