FDA.reportPublic FDA data

Heartflow Analysis

Primary DI
00853341006701
Brand
Heartflow Analysis
Company
Heartflow, Inc.
Model
4.x
Published
2025-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
PJACoronary Vascular Physiologic Simulation Software
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
PJACoronary Vascular Physiologic Simulation SoftwareCardiovascular2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250902000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250902000HeartFlow AnalysisHeartFlow, Inc.2025-07-18PJA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853341006701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853341006701008533410067018533410067010853341006701

GMDN Terms#

Term, Definition table
TermDefinition
Vascular modelling softwareA stand-alone software application intended to aid assessment of vascular stenosis and/or endovascular interventions, by producing a three-dimensional (3-D) cardiovascular model which has features of predicted blood flow data and/or endovascular device deployments. It typically uses computed tomography (CT) images and may be intended as an alternative to invasive techniques (i.e., invasive blood pressure, invasive fractional flow reserve, angiography); it is not intended to store patient records. It is designed to be installed on an off-the-shelf computer/smart device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
804411283
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853341006060HeartFlow AnalysisFFRct version 32022-12-21
00853341006053HeartFlow AnalysisFFRct version 32021-06-08
00853341006039HeartFlow AnalysisFFRct version 22020-04-08
00853341006008FFRctv2.12016-08-01
00853341006015FFRctv2.12016-12-06
00853341006022FFRctv2.182019-02-01

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Primary DI, Brand, Company table
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08437023642016NemoCastSOFTWARE NEMOTEC SLLLZ2026-04-23
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08437023642047NemoScanSOFTWARE NEMOTEC SLQIH2026-04-23
EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
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08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03