gudid Primary ID: 8.5.3

Vitrea Read (UDI 8.5.3)

Manufactured by Canon Medical Informatics A/S

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Vitrea Read (Model/Catalog Number: 8.5.3) is a medical device manufactured by Canon Medical Informatics A/S. This product is indexed under FDA Product Code / Category Classification LMD within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 8.5.3
Product Code / EMDN: LMD
Device Name: 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.
Database Sync Date: 2026-08-09 09:32:43

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of Vitrea Read?

The registered manufacturer of record for Vitrea Read is Canon Medical Informatics A/S.

What is the Primary UDI-DI identifier for Vitrea Read?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 8.5.3.

What classification code is assigned to this device?

This device is registered under product classification code LMD.

Similar Classification Devices (LMD)

Other Devices by Canon Medical Informatics A/S

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