HeartFlow FFRct Analysis

510(k) Number

K190925 ↗

FDA Product Code

PJA

Device Class

Class II

Regulation

21 CFR Part 870.1415

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• HeartFlow Analysis FFRct version 3

  Class II

  GUDID on market

• HeartFlow Analysis FFRct version 2

  Class II

  GUDID on market

• FFRct v2.18

  Class II

  GUDID on market

• FFRct v2.1

  Class II

  GUDID on market

• FFRct

  Class II

  FDA 510(k) K182035 Active Cleared 6 Dec 2018

• Heartflow Ffrct

  Class II

  FDA De Novo DEN130045 Active Cleared 26 Nov 2014 FDA 510(k)

See all devices from HeartFlow, Inc. →

• How does the HeartFlow FFRct Analysis software help clinicians assess coronary artery stenosis without invasive procedures?

  The HeartFlow FFRct Analysis simulates fractional flow reserve (FFR) using data from computed tomography angiography (CTA). This allows clinicians to evaluate the physiologic impact of coronary artery stenosis—determining whether a blockage is functionally significant—without needing invasive coronary angiography or placing catheters inside the arteries. It provides lesion-specific insights to guide decisions on whether revascularization (like angioplasty or stenting) is necessary.

• Is the HeartFlow FFRct Analysis software reusable for multiple patients, or is it intended for single-use per analysis?

  The software is designed for single-use per patient analysis. Since it processes CTA data to generate physiologic simulations, each analysis is tailored to an individual patient’s coronary anatomy. There’s no physical device to sterilize or reuse—only the digital tool itself, which remains on the system for repeated use across different patients.

• What kind of integration does the HeartFlow FFRct Analysis require with existing medical imaging systems?

  The software is a digital tool meant to integrate with CTA imaging systems already in use within cardiovascular clinical settings. It relies on CTA data to perform its FFR simulation, so it must be compatible with the imaging software and workflows where the scans are acquired and stored. No additional hardware or physical components are required beyond standard IT infrastructure.

• Does the HeartFlow FFRct Analysis have any special storage or disposal requirements beyond standard IT protocols?

  No special storage or disposal requirements are specified beyond standard IT protocols for digital medical software. Since it’s a non-invasive, software-based diagnostic tool with no physical components, concerns like sterilization or disposal don’t apply. The software operates within MRI-safe environments and is designed for use in clinical settings where CTA data is routinely handled.

• What regulatory pathways does the HeartFlow FFRct Analysis follow, and how does that affect its use in clinical practice?

  The software is authorized under both FDA 510(k) clearance (K190925) and EU MDR compliance, confirming it meets U.S. and European regulatory standards for coronary vascular physiologic simulation devices. This clearance indicates it’s been deemed substantially equivalent to a predicate device and complies with safety and performance requirements. Clinicians can rely on its regulatory status to ensure it’s intended for use as a non-invasive diagnostic aid in cardiovascular settings, though actual use must align with local medical guidelines and institutional protocols.