Acteon Imaging Suite W0900046

GUDID D804W09000460

Acteon Imaging Suite software program is an application software for general dental and maxillofacial diagnostic imaging. It controls exam retrieval, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.

DE GOTZEN SRL

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• Primary Device ID: D804W09000460
• NIH Device Record Key: 5fe3fa1c-d276-4e44-b340-e8331e0be07b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acteon Imaging Suite
• Version Model Number: ACTEON IMAGING SUITE
• Catalog Number: W0900046
• Company DUNS: 433051802
• Company Name: DE GOTZEN SRL
• 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: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D804W09000460 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192165

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2020-04-16
• Device Publish Date: 2020-04-08

On-Brand Devices [Acteon Imaging Suite]

• D804W09000460: Acteon Imaging Suite software program is an application software for general dental and maxillof
• D8049902630: Acteon Imaging Suite software program is an application software for general dental and maxillof