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QXXClass II

Coronary Artery Disease Machine Learning-Based Notification Software

21 CFR 870.2380 / Cardiovascular
FDA source (opens on fda.gov)

QXX is the FDA product code for Coronary Artery Disease Machine Learning-Based Notification Software, a class II device type, regulated under 21 CFR 870.2380. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QXX
Device name
Coronary Artery Disease Machine Learning-Based Notification Software
FDA definition
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.
Regulation
21 CFR 870.2380
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QXX

By decision year
1 clearance under product code QXX with a decision year between 2023 and 2023, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QXX by decision year
YearClearances
20231

Applicants with the most clearances

Product code QXX
Applicants holding the most 510(k) clearances under product code QXX
ApplicantClearances
Corvista Health, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code