Vitrea

Basic Information

• Brand Name: Vitrea
• Primary DI: 00853866003216
• Version / Model: 7.3.2
• Company Name: Canon Medical Informatics, Inc.
• Labeler DUNS: 160061651
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-22
• Public Version: 7
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: 056965df-2235-4585-ac8a-9a14f516ab72

Device Description

Vitrea® software is an advanced visualization solution from Vital that creates 2D, 3D, and 4D images of human anatomy from image data from multiple modalities. With this tool, physicians can easily navigate within these images to better understand disease conditions. Vitrea addresses specialists’ needs through various software options for cardiac, colon, vessel probe, and other applications. In addition, Vitrea software utilizes an intuitive clinical workflow and automatic settings to improve speed and simplicity.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JAK	System, X-Ray, Tomography, Computed	Radiology	892.1750	2
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41670	Radiological PACS software	An individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853866003216	GS1

Premarket Submissions

Submission Number	Supplement Number
K032748	000
K052632	000
K071331	000
K071362	000
K072821	000
K121213	000
K122578	000
K140395	000
K141302	000
K143079	000
K150104	000
K150258	000
K151115	000
K151283	000
K151919	000
K160150	000
K161157	000
K161419	000