Cardiovascular · 510(k) · 2025
CardioVision
Icardio.Ai. Cleared by FDA on 21 November 2025 under submission K251293, product code QUO (adjunctive heart failure status indicator). What FDA's record says, in FDA's words.
Device record · K251293
- Device. CardioVisionDEVICE
- Company. Icardio.AiCOMPANY
- Decision. 21 November 2025, 510(k), substantially equivalent (traditional review); received 25 April 2025DECISION
- Panel. CardiovascularPANEL
- Product code. QUO, Adjunctive Heart Failure 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.
The iCardio.ai CardioVision AI is an automated machine learning–based decision support system, indicated as a diagnostic aid for patients undergoing an echocardiographic exam consisting of a single PLAX view in an outpatient environment, such as a primary care setting. When utilized by an interpreting clinician, this device provides information that may be useful in detecting moderate or severe aortic stenosis. iCardio.ai CardioVision AI is indicated in adult populations over 21 years of age. Patient management decisions should not be made solely on the results of the iCardio.ai CardioVision AI analysis. iCardio.ai CardioVision AI analyzes a single cine-loop DICOM of the parasternal long axis (PLAX).
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 Icardio.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.