Pulmonary Hypertension Machine Learning-Based Notification Software
Pulmonary hypertension machine learning-based notification software is a cardiovascular software device that employs machine learning techniques to suggest the likelihood of pulmonary hypertension in a patient, intended to prompt further referral or diagnostic follow-up rather than to provide a definitive diagnosis. It is classified as FDA Class II (510(k) required) under regulation 870.2380 in the Cardiovascular specialty, with product code SAT. The device is not an implant and does not support life-sustaining functions.
Research product code SAT 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
- SAT
- Device Class
- FDA class 2
- Regulation Number
- 870.2380
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
Pulmonary hypertension machine learning-based notification software employs machine learning techniques to suggest the likelihood of pulmonary hypertension for further referral or diagnostic follow-up.
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 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.