Heartflow Analysis

GUDID 00853341006701

Heartflow, Inc.

Vascular modelling software

• Primary Device ID: 00853341006701
• NIH Device Record Key: 71585f1c-99e8-49a9-99fc-661f796172ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Heartflow Analysis
• Version Model Number: 4.x
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853341006701 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250902

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2025-09-29
• Device Publish Date: 2025-09-20

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
• 00853341006701: 4.x