Vitrea Read

GUDID 00628105001106

Vitrea Read is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data from various imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. Vitrea Read enables healthcare professionals and physicians to access patients’ medical images for making all patient management decisions.

Canon Medical Informatics A/S

Radiological PACS software

• Primary Device ID: 00628105001106
• NIH Device Record Key: ceceb466-fa35-4dbe-82d9-2aa12ea931d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vitrea Read
• Version Model Number: 9.0.0
• Company DUNS: 307092283
• Company Name: Canon Medical Informatics A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628105001106 [Primary]

FDA Product Code

• LMD: System, Digital Image Communications, 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: 2024-01-29
• Device Publish Date: 2024-01-19

On-Brand Devices [Vitrea Read]

• 00628105001007: Vitrea Read is a software only medical device providing tools and features that may be used for
• 00628105001038: Vitrea Read is a software only medical device providing tools and features that may be used for
• 00628105001052: Vitrea Read is a software only medical device providing tools and features that may be used for
• 00628105001076: Vitrea Read is a software only medical device providing tools and features that may be used for
• 00628105001045: Vitrea Read is a software only medical device providing tools and features that may be used for
• 00628105001090: Vitrea Read is a software only medical device providing tools and features that may be used for
• 00628105001113: Vitrea Read is a software only medical device providing tools and features that may be used for
• 00628105001137: Vitrea Read is a software only medical device providing tools and features that may be used for
• 00628105001120: Vitrea Read is a software only medical device providing tools and features that may be used for
• 00628105001106: Vitrea Read is a software only medical device providing tools and features that may be used for
• 00628105001144: Vitrea Read is a software only medical device providing tools and features that may be used for
• 00628105001151: Vitrea Read is a software only medical device providing tools and features that may be used for