HeartFlow, Inc.

United States US-MF-000020729 Last updated 23 Oct 2026

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Devices: 12
Registries: EUDAMEDGUDIDFDA 510(k)FDA
FDA recalls: 0

Catalogue12

HeartFlow Analysis FFRct version 3 Ref FFRct version 3

Class II FDA UDI Active
HeartFlow Analysis FFRct version 3 Ref FFRct version 3

Class II FDA UDI Active
HeartFlow Analysis FFRct version 2 Ref FFRct version 2

Class II FDA UDI Active
FFRct v2.18 Ref v2.18

Class II FDA UDI Active
FFRct v2.1 Ref v2.1

Class II FDA UDI Active
FFRct v2.1 Ref v2.1

Class II FDA UDI Active
HeartFlow FFRct Analysis Ref K190925

Class II FDA 510(k) Active
FFRct Ref K182035

Class II FDA 510(k) Active
FFRct Ref K161772

Class II FDA 510(k) Active
FFRct Ref K152733

Class II FDA 510(k) Active
Heartflow Ffrct Ref DEN130045

Class II FDA 510(k) Active
Heartflow Analysis Ref HeartFlow Analysis v4.x

Class IIb EUDAMEDFDA UDI Active

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

Notified body 2797 1 certificate

MDR 808955 Amended

Quality management system EU MDR

Issued
22 May 2026

Expires
31 Mar 2030

Reason
Other

Authorised representatives

MDSS GmbH DE

Notified bodies

Notified body 2797

What HeartFlow, Inc. makes

HeartFlow, Inc. develops vascular modelling software, including the HeartFlow Analysis suite and the FFRct (fractional flow reserve computed tomography) analysis tools.

These software products are classified as Class II and Class IIb medical devices and are listed in the EUDAMED database as well as the FDA 510(k) and FDA UDI registries; the company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does HeartFlow, Inc. make?

HeartFlow, Inc. develops vascular modelling software, including the HeartFlow Analysis suite and the FFRct (fractional flow reserve computed tomography) analysis tools, which are software products used for medical diagnostics.

Where is HeartFlow, Inc. based?

HeartFlow, Inc. is based in the United States, as stated in the company's country information within the provided device data.

Which regulatory registries list HeartFlow, Inc.'s devices?

HeartFlow, Inc.'s devices are listed in the EUDAMED database, the FDA 510(k) registry, and the FDA UDI registry, as indicated in the LISTED IN field of the device data.

How are HeartFlow, Inc.'s devices classified?

HeartFlow, Inc.'s devices are classified as Class II and Class IIb medical devices, according to the DEVICE CLASSES field in the provided information.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 135, Main St, San Francisco, CA, United States
Website: www.heartflow.com
Email: [email protected]
Phone: +16502410500
PRRC contact: Larry Carrier
EUDAMED SRN: US-MF-000020729
FDA FEI number: 3021637148
DUNS number: 804411283

Catalogue12

HeartFlow Analysis FFRct version 3 Ref FFRct version 3

HeartFlow Analysis FFRct version 3 Ref FFRct version 3

HeartFlow Analysis FFRct version 2 Ref FFRct version 2

FFRct v2.18 Ref v2.18

FFRct v2.1 Ref v2.1

FFRct v2.1 Ref v2.1

HeartFlow FFRct Analysis Ref K190925

FFRct Ref K182035

FFRct Ref K161772

FFRct Ref K152733

Heartflow Ffrct Ref DEN130045

Heartflow Analysis Ref HeartFlow Analysis v4.x