Cardiovascular Machine Learning-Based Notification Software
The cardiovascular machine learning-based notification software (product code QXO) is a Class 2 Cardiovascular device (regulation 870.2380) that employs machine learning techniques to suggest the likelihood of a cardiovascular disease or condition for further referral or diagnostic follow-up. Requiring 510(k) clearance, the software identifies a single condition based on one or more non-invasive physiological inputs as part of routine medical care and is intended as the basis for further testing rather than as a diagnostic tool. It is not intended to identify or detect arrhythmias, and is not an implant or life-sustaining.
Research product code QXO in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- QXO
- Device Class
- FDA class 2
- Regulation Number
- 870.2380
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
Cardiovascular machine learning-based notification software employs machine learning techniques to suggest the likelihood of a cardiovascular disease or condition for further referral or diagnostic follow-up. The software identifies a single condition based on one or more non-invasive physiological inputs as part of routine medical care. It is intended as the basis for further testing and is not intended to provide diagnostic quality output. It is not intended to identify or detect arrhythmias.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.