Device class
Class II
Regulation 870.2380
Total clearances
3
2024-04-05 → 2026-08-21
Definition
What is Pulmonary Hypertension Machine Learning-Based Notification Software
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.
Classification details
Medical specialty
Cardiovascular
Regulation number
870.2380
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Analytics For Life, Inc. |
1 |
0 |
2024-04-05 |
|
Anumana, Inc.
|
1 |
1 |
2026-03-28 |
|
Tempus AI, Inc.
|
1 |
1 |
2026-08-21 |
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
|
— |
Medium
|
CPT for electrocardiogram, baseline for pulmonary hypertension screening software |
| 94060 |
CPT
|
— |
Medium
|
CPT for spirometry, pulmonary function assessment supporting PH diagnosis |
Pulse
Most recent 510(k) clearances