HeartPro

GUDID 17540266000029

HeartPro is a web-accessible, self-contained image analysis software application that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartPro specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images.

Medvoxel Diagnostics Inc

MRI system application software

• Primary Device ID: 17540266000029
• NIH Device Record Key: b5dfd7a5-5f37-400f-9b08-30d7342bcd92
• Commercial Distribution Discontinuation: 2020-04-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: HeartPro
• Version Model Number: 4.6
• Company DUNS: 245239665
• Company Name: Medvoxel Diagnostics 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-604-343-6396
• Email: support@medvoxel.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	17540266000029 [Primary]

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-04-08
• Device Publish Date: 2019-01-08

On-Brand Devices [HeartPro]

• 17540266000012: HeartPro is a web-accessible, self-contained image analysis software application that analyzes D
• 17540266000029: HeartPro is a web-accessible, self-contained image analysis software application that analyzes D