Heartflow Ffrct
by Heartflow United States 510(k)
510(k) DEN130045
Product code PJA
Overview
The Heartflow FFRCT Analysis is a coronary vascular physiologic simulation software designed for quantitative and qualitative analysis of previously acquired Computed Tomography (CT) DICOM data. It calculates FFRCT, a mathematically derived metric simulating fractional flow reserve by analyzing simulated pressure, velocity, and blood flow data from coronary arteries. This software aids in assessing coronary artery disease in clinically stable symptomatic patients by providing non-invasive physiologic insights.
The device is supplied as software for use with existing CT imaging systems and does not require additional hardware. It operates on standard computing platforms and is intended for single-use per CT scan analysis, though the software itself may be reused across multiple analyses. Authorized under FDA 510(k) clearance (K130045), it adheres to regulatory standards for Class II medical devices under 21 CFR 870.1415, with no specific sterility or MRI safety requirements stated. Storage and usage follow standard IT and medical imaging protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA De NovoDENG | NumberDEN130045 | Date26 Nov 2014 | StatusActive |
Coverage
- Active
- Not covered
United States — FDA De Novo Active
Specification
- 510(k) Number
- FDA Product Code
- PJA
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1415
- Advisory Committee
- Cardiovascular
- FDA Decision
- DENG De Novo granted
Other devices from HeartFlow, Inc.
Questions
What clinical scenario is the Heartflow FFRCT Analysis intended to support in patient evaluation?
The Heartflow FFRCT Analysis is designed to help evaluate coronary artery disease in clinically stable symptomatic patients by providing a non-invasive way to assess physiologic insights. It simulates fractional flow reserve (FFR) using CT scan data, allowing clinicians to assess blood flow and pressure in coronary arteries without invasive procedures like coronary angiography.
How is the Heartflow FFRCT Analysis supplied, and does it require any additional hardware?
The Heartflow FFRCT Analysis is supplied purely as software and does not require any extra hardware beyond existing CT imaging systems. It runs on standard computing platforms, meaning it integrates with your current diagnostic infrastructure without needing specialized equipment.
Is the software reusable for multiple patient analyses, or is it intended for single-use?
The software itself is reusable across multiple CT scan analyses, but it is intended for single-use per patient scan—meaning each analysis corresponds to one patient’s CT data. This allows for repeated use of the software tool while maintaining patient-specific results.
What storage and handling requirements apply to the Heartflow FFRCT Analysis?
Since the Heartflow FFRCT Analysis is a software-based solution, its storage and usage follow standard IT and medical imaging protocols. This includes maintaining secure, compliant digital storage for CT data and ensuring the software environment meets medical-grade computing standards for reliability and data integrity.
What regulatory pathway was followed for the Heartflow FFRCT Analysis, and what class does it fall under?
The Heartflow FFRCT Analysis was cleared through the FDA 510(k) pathway under clearance number K130045 and is classified as a Class II medical device under 21 CFR 870.1415. This classification aligns with its role as a coronary vascular physiologic simulation tool for diagnostic purposes.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) DEN130045