AccessGUDID - DEVICE: IMAGE-ARENA (04260361440150)

GUDID

Device Identifier (DI) Information

Brand Name: IMAGE-ARENA
Version or Model: IA4
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: TOMTEC Imaging Systems GmbH

Primary DI Number: 04260361440150
Issuing Agency: GS1
Commercial Distribution End Date: February 21, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 537711462 *Terms of Use

Device Description: The IMAGE-ARENA software platform is intended to import, export, store, retrieve and report digital studies. The IMAGE-ARENA software can import certain digital 2D or 3D image file formats of different modalities. IMAGE-ARENA offers a Generic Clinical Application Package interface in order to connect TOMTEC applications as well as commercially available analysis and quantification tools to the IMAGE-ARENA platform. It is intended as a general purpose digital medical image processing tool. IMAGE-ARENA is not intended to be used for reading of mammography images.

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):	Yes
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
LLZ	System, Image Processing, Radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: a8ea6896-d9c6-44ca-ad99-2e086c8cfa2c
Public Version Date: October 18, 2023
Public Version Number: 10
DI Record Publish Date: June 06, 2016