Device class
Class II
Regulation 892.1600
Total clearances
6
2021-09-10 → 2025-10-17
Definition
What is X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
X-ray angiographic imaging based coronary vascular simulation software device is a prescription device that provides an image analysis tool to assess blood flow in the coronary vascular system using X-ray angiographic imaging data. X-ray angiographic imaging based coronary vascular simulation software device solves algorithms and yields simulation-based metrics for certain cardiology applications. X-ray angiographic imaging based coronary vascular simulation software device cannot be used alone for clinical decision making and clinical management, and is a tool intended to generate results for use and review by a qualified clinician.
Classification details
Medical specialty
Radiology
Regulation number
892.1600
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 |
| 0503T |
CPT
|
— |
Medium
|
Coronary vascular imaging analysis; emerging code for imaging-based coronary software |
| 93571 |
CPT
|
— |
Medium
|
Intravascular ultrasound (coronary); image analysis for coronary blood flow assessment |
| 93000 |
CPT
|
— |
Low
|
Electrocardiogram; may support coronary risk assessment application |
Pulse
Most recent 510(k) clearances