Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021637148

FEI Number

3021637148

Entity Name

HEARTFLOW, INC.

City/State/Country

San Francisco, CA, US

Establishment Address

135 Main St Ste 1000, San Francisco, CA 94105, US

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

HeartFlow, Inc. (Owner Number: 10048116)

Owner / Operator Contact Address

135 Main St Ste 1000, San Francisco, CA 94105, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213857

PMA Number

N/A

All Registered Proprietary Names

HeartFlow FFRCT Analysis Heartflow Analysis HeartFlow FFRCT Analysis

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PJA	Coronary Vascular Physiologic Simulation Software	Cardiovascular	Class 2	870.1415	2021-01-15
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-09-15
PJA	Coronary Vascular Physiologic Simulation Software	Cardiovascular	Class 2	870.1415	2025-09-15
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-09-15
PJA	Coronary Vascular Physiologic Simulation Software	Cardiovascular	Class 2	870.1415	2022-12-13
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-12-13

Official Correspondent

Mazi Kiani

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HeartFlow, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K242270	Orthofix Srl	OrthoNext Platform System	2024-12-19
K261713	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.6.0)	2026-06-18
K243647	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.5)	2025-06-30
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Similar Registrations

Registration Number	Establishment Name	Location
3025430791	KEYA MEDICAL TECHNOLOGY CO.,LTD.	Beijing, CN
3042928350	Computer Vision AG	Wallisellen Zurich, CH
3021027284	ANGIOWAVE IMAGING, INC.	Concord, MA, US
3030088963	REBRAIN	PESSAC Gironde, FR
3042852277	REMEDY LOGIC	New York, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021637148. Last updated year: 2026. Please use registration number 3021637148 when referencing this establishment in official correspondence.