M'Ath PACS

GUDID 03760264690115

I M T

Cardiovascular risk/probability assessment interpretive software

• Primary Device ID: 03760264690115
• NIH Device Record Key: c2f839bc-a63e-44be-b919-39b62322c7a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M'Ath PACS
• Version Model Number: 3.2.1
• Company DUNS: 266778164
• Company Name: I M T
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• 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: 404.808.1842
• Email: jelkins@medquestmail.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760264690115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040686

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: 2019-10-02
• Device Publish Date: 2019-09-24