Cardiovascular · 510(k) · 2023
CorVista System
CorVista Health, Inc.. Cleared by FDA on 8 September 2023 under submission K232686, product code QXX (coronary artery disease machine learning-based notification software). What FDA's record says, in FDA's words.
Device record · K232686
- Device. CorVista SystemDEVICE
- Company. CorVista Health, Inc.COMPANY
- Decision. 8 September 2023, 510(k), substantially equivalent (traditional review); received 1 September 2023DECISION
- Panel. CardiovascularPANEL
- Product code. QXX, Coronary Artery Disease Machine Learning-Based Notification SoftwareCODE
- Regulation. 21 CFR 870.2380, Class IIREG
- Source. FDA database entry · decision document (15 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 CorVista System analyzes sensor-acquired physiological signals of patients presenting with cardiovascular symptoms (such as chest pain, dyspnea, fatigue) to indicate the likelihood of significant coronary artery disease . The analysis is presented for interpretation by healthcare providers in conjunction with their clinical judgment, the patient’s signs, symptoms, and clinical history as an aid in diagnosis.
The product code's definition, from FDA's classification record. Coronary Artery Disease machine learning-based notification software employs machine learning techniques to suggest the likelihood of coronary artery disease for further referral or diagnostic follow-up.
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.
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QXX. 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 QXX, in Cardiovascular, or cleared in 2023. 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.