Device class
Class II
Regulation 870.2380
Total clearances
5
2023-09-28 → 2025-09-19
Definition
What is Reduced Ejection Fraction Machine Learning-Based Notification Software
Reduced Ejection Fraction machine learning-based notification software employs machine learning techniques to suggest the likelihood of a reduced ejection fraction for further referral or diagnostic follow-up.
Classification details
Medical specialty
Cardiovascular
Regulation number
870.2380
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 93000 |
CPT
|
— |
Low
|
Reduced ejection fraction detection software; diagnostic software typically bundled into echocardiography or ECG codes |
Pulse
Most recent 510(k) clearances