TOMTEC-ARENA

GUDID 04260361440181

TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to be used for reading of mammography images.

TOMTEC Imaging Systems GmbH

Radiology PACS software

• Primary Device ID: 04260361440181
• NIH Device Record Key: 4900959a-c1ad-4b43-944d-cb1e38c454c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOMTEC-ARENA
• Version Model Number: TTA2.50
• Company DUNS: 537711462
• Company Name: TOMTEC Imaging Systems GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260361440181 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213544

FDA Product Code

• QIH: Automated Radiological Image Processing Software

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: 2022-01-31
• Device Publish Date: 2022-01-21

On-Brand Devices [TOMTEC-ARENA]

• 04260361440167: TOMTEC-ARENA software is a clinical software package designed for review, quantification and rep
• 04260361440174: TOMTEC-ARENA software is a clinical software package designed for review, quantification and rep
• 04260361440198: TOMTEC-ARENA software is a clinical software package designed for review, quantification and rep
• 04260361440181: TOMTEC-ARENA software is a clinical software package designed for review, quantification and rep
• 04260361440204: TOMTEC-ARENA software is a clinical software package designed for review, quantification and rep
• 04260361440211: TOMTEC-ARENA software is a clinical software package designed for review, quantification and rep