WebPAX® n/a

GUDID B127WP90

WebPAX® is intended for use in the communication and storage of medical images. WebPAX® is also intended for use as a comprehensive solution to view,

HEART IMAGING TECHNOLOGIES, LLC

Medical image management system

• Primary Device ID: B127WP90
• NIH Device Record Key: 1eeedab3-5828-49df-b09e-136ea3728aaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WebPAX®
• Version Model Number: 9
• Catalog Number: n/a
• Company DUNS: 194348913
• Company Name: HEART IMAGING TECHNOLOGIES, LLC
• 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: 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
HIBCC	B127WP90 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152949

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-26