HeartFlow Analysis

GUDID 00853341006039

The HeartFlow Analysis is coronary physiologic simulation software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries. The software displays the anatomy combined with functional information using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the clinician in the assessment and treatment planning of coronary artery disease. The HeartFlow Analysis is performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.

HEARTFLOW, INC.

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• Primary Device ID: 00853341006039
• NIH Device Record Key: e9515eb4-e12c-4884-acaf-a8ec52aad9c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeartFlow Analysis
• Version Model Number: FFRct version 2
• Company DUNS: 804411283
• Company Name: HEARTFLOW, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +16502410500
• Email: support@heartflow.com
• Phone: +16502410500
• Email: support@heartflow.com
• Phone: +16502410500
• Email: support@heartflow.com
• Phone: +16502410500
• Email: support@heartflow.com
• Phone: +16502410500
• Email: support@heartflow.com
• Phone: +16502410500
• Email: support@heartflow.com
• Phone: +16502410500
• Email: support@heartflow.com
• Phone: +16502410500
• Email: support@heartflow.com
• Phone: +16502410500
• Email: support@heartflow.com
• Phone: +16502410500
• Email: support@heartflow.com
• Phone: +16502410500
• Email: support@heartflow.com
• Phone: +16502410500
• Email: support@heartflow.com
• Phone: +16502410500
• Email: support@heartflow.com
• Phone: +16502410500
• Email: support@heartflow.com
• Phone: +16502410500
• Email: support@heartflow.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853341006039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190925

FDA Product Code

• PJA: Coronary Vascular Physiologic Simulation Software

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-16
• Device Publish Date: 2020-04-08

On-Brand Devices [HeartFlow Analysis]

• 00853341006039: The HeartFlow Analysis is coronary physiologic simulation software developed for the clinical qu
• 00853341006053: The HeartFlow Analysis is coronary physiologic simulation software developed for the clinical qu