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Intended Use

HeartFlow FFRCT is a coronary physiologic simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides FFRCT, a mathematically derived quantity, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. FFRCT analysis is intended to support the functional evaluation of coronary artery disease. The results of this analysis are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries.

Technology

The HeartFlow FFRCT device is a software medical device that quantitatively and qualitatively analyzes Coronary Computed Tomography Angiography (cCTA). It generates a 3D computer model from previously acquired CT images and simulates physiological blood flow parameters such as pressure and velocity to support coronary artery disease assessment. It operates independently of imaging equipment vendors and acquisition protocols.

Performance

The software underwent design, development, testing, and validation including stress and repeatability tests. The device was previously reviewed under predicate K161772 and deemed acceptable for use. The current submission includes no new clinical or preclinical data as the product functionality and architecture remain unchanged.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    7/30/2018

    4 months
  • 2

    FDA Approval

    12/6/2018

Other devices from HeartFlow, Inc

View all 6 devices

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