ImageQube

GUDID B688IMAGEQUBE0

ImageQube, Intuitive Imaging Informatics Picture Archiving and Communication System (PACS), is a medical imaging information system that securely tra

INTUITIVE IMAGING INFORMATICS, LLC

Radiology picture archiving and communication system workstation

• Primary Device ID: B688IMAGEQUBE0
• NIH Device Record Key: 5d6e6f33-3a7e-422d-b191-d6cfef01d6a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImageQube
• Version Model Number: ImageQube
• Company DUNS: 086797144
• Company Name: INTUITIVE IMAGING INFORMATICS, 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: 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
HIBCC	B688IMAGEQUBE0 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-22
• Device Publish Date: 2018-09-20