Image-Arena

GUDID 04260361440150

Tom Tec Imaging Systems GmbH

Radiology picture archiving and communication system application software

• Primary Device ID: 04260361440150
• NIH Device Record Key: a8ea6896-d9c6-44ca-ad99-2e086c8cfa2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Image-Arena
• Version Model Number: 4.6
• Company DUNS: 327141016
• Company Name: Tom Tec 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260361440150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110667

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-24
• Device Publish Date: 2016-06-06

Devices Manufactured by Tom Tec Imaging Systems GmbH

• 04260361440143 - TomTec-Arena: 2018-09-24
• 04260361440150 - Image-Arena: 2018-09-24
• 04260361440150 - Image-Arena: 2018-09-24