Device class
Class II
Regulation 870.1415
Total clearances
4
2021-01-08 → 2025-07-18
Definition
What is Coronary Vascular Physiologic Simulation Software
A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.
Classification details
Medical specialty
Cardiovascular
Regulation number
870.1415
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
HeartFlow, Inc.
|
3 |
0 |
2025-07-18 |
|
Keyamed Na, Inc. |
1 |
0 |
2022-04-01 |
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
|
Electrocardiography as baseline for coronary vascular assessment |
| 93040 |
CPT
|
— |
Medium
|
Rhythm strip ECG relevant to physiologic simulation context |
Pulse
Most recent 510(k) clearances