Skip to content

HeartFlow Analysis v4.x

by HeartFlow, Inc. United States EUDAMED510(k)GUDID

Ref HeartFlow Analysis v4.x, Heartflow Analysis v4.xModel 4.x510(k) K250902

Product code PJAEMDN Z11069092

Overview

HeartFlow Analysis is a Coronary Vascular Physiologic Simulation Software (Nomenclature Code: Z11069092), designed to simulate coronary artery physiology using computed tomography angiography (CTA) data. It provides quantitative flow ratio (QFR) analysis to assess coronary artery stenosis and blood flow dynamics, aiding in the evaluation of coronary artery disease.

This software is intended for use in non-sterile, non-reusable settings by healthcare professionals in cardiovascular diagnostics. Supplied as a digital tool, it operates on compatible medical imaging systems and requires no sterilization or reprocessing. Authorized under FDA 510(k) clearance and MDR, it adheres to Class IIb regulatory standards and is distributed by HeartFlow, Inc. (US-MF-000020729) and MDSS GmbH (DE-AR-000005430).

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number00853341006FFRCTGJ Basic UDI-DIDate28 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00853341006701 UDI-DIDate20 Sep 2025ListedStatusIn distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK250902 Date18 Jul 2025ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 22 Oct 2026

Full name
Heartflow Analysis
Generic Name
Vascular modelling software
Model / Reference
4.x, HeartFlow Analysis v4.x
Primary DI / UDI-DI
00853341006701
Basic UDI-DI
00853341006FFRCTGJ, 0853341006FFRCTSW
510(k) Number
FDA Product Code
LLZ, QIH, PJA
EMDN Code
Z11069092 Various digital bioimaging management instruments - medical device software
GMDN Term
Vascular modelling software
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.2050, 870.1415
Special Device Type
Software
Market of Registration
Belgium
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000020729
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from HeartFlow, Inc.

See all devices from HeartFlow, Inc. →

Questions

  • What is the primary clinical purpose of HeartFlow Analysis, and how does it differ from traditional coronary angiography methods?

    HeartFlow Analysis is a software tool designed to simulate coronary artery physiology using data from computed tomography angiography (CTA). It provides quantitative flow ratio (QFR) analysis, which evaluates coronary artery stenosis and blood flow dynamics without invasive procedures. Unlike traditional coronary angiography, which requires catheterization and contrast dye injection, HeartFlow Analysis offers a non-invasive, digital alternative to assess coronary artery disease by analyzing existing CTA scans.

  • Is HeartFlow Analysis a single-use or reusable device, and what are the storage requirements?

    HeartFlow Analysis is a digital software tool supplied for non-reusable use in non-sterile settings. Since it operates on compatible medical imaging systems, there are no physical storage requirements like packaging or sterilization. It is intended for repeated use across different patients as long as the software remains active and compatible with the imaging system.

  • Who are the authorized distributors of HeartFlow Analysis, and how can I verify its regulatory compliance?

    HeartFlow Analysis is distributed by HeartFlow, Inc. (US-MF-000020729) in the United States and MDSS GmbH (DE-AR-000005430) in Europe. The device holds FDA 510(k) clearance and MDR authorization, adhering to Class IIb regulatory standards. Compliance can be verified through the UDI (Unique Device Identifier) or by checking the manufacturer’s official documentation, which includes the UDI data (e.g., 00853341006FFRCTGJ).

  • Does HeartFlow Analysis require any special hardware or imaging systems to function, and what version is currently authorized?

    HeartFlow Analysis operates as a digital tool and requires compatibility with existing medical imaging systems that generate CTA data. The latest authorized version is HeartFlow Analysis v4.x, as referenced in the regulatory submissions. Ensure your imaging system supports the software’s integration for accurate QFR analysis.

  • How is HeartFlow Analysis classified under regulatory standards, and what does this mean for its use in clinical settings?

    HeartFlow Analysis is classified as a Class IIb medical device under FDA and MDR regulations, indicating moderate risk. This classification means it undergoes stringent review for safety and effectiveness before market authorization. Clinically, this ensures the software meets rigorous standards for coronary artery disease assessment while requiring healthcare professionals to follow established protocols for its use in diagnostics.

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
Other properties (23)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (4)

  • EUDAMED 957b8a4a-9dbe-4501-b143-c7810fb72a31 85 fields · synced 22 Oct 2026
  • FDA UDI 71585f1c-99e8-49a9-99fc-661f796172ef 33 fields · synced 30 May 2026
  • EUDAMED 00853341006701|0853341006FFRCTSW 61 fields · synced 7 Oct 2026
  • FDA 510(k) K203329 1 fields · synced 18 May 2026