510(k) K243769

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

April 4, 2025

Date Received

December 6, 2024

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device

Device Class

Class II

Regulation Number

892.1600

Review Panel

RA

Submission Type

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.