AccessGUDID - DEVICE: Vitrea (00853866003179)

GUDID

Device Identifier (DI) Information

Brand Name: Vitrea
Version or Model: 6.9
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Canon Medical Informatics, Inc.

Primary DI Number: 00853866003179
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 160061651 *Terms of Use

Device Description: Vitrea® is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography. Vitrea provides visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea user interface follows typical clinical workflow patterns to process, review, and analyze digital images. It is a web-based imaging system that allows physicians to use PCs or notebook computers to remotely access to 2D and 3D advanced visualization using a Microsoft web-enabled browser. Vitrea modules include automated and semi-automated visualization and advanced quantification tools targeted for a specific study based on a protocol selected by the user. The automation is only intended to reduce the manual steps required by the user to analyze and quantify the data from the images; it is not intended to detect pathology or disease. The software provides imaging information as an assist to the physician.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAK	System, X-Ray, Tomography, Computed
LLZ	System, Image Processing, Radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K032748	000
K040305	000
K043333	000
K052632	000
K071331	000
K071362	000
K072821	000
K121213	000
K122578	000
K140395	000
K141302	000
K143079	000
K150104	000
K151919	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a9f0323e-5e3a-40a2-a1ac-04a80a690d8a
Public Version Date: October 18, 2023
Public Version Number: 7
DI Record Publish Date: November 07, 2016