Visaris Avanse

GUDID 08606102809033

Visaris Avanse® is a digital radiography imaging, control and management software (for imaging consoles) that works with DR flat panel detectors technology. Visaris Avanse® PACS provides functionality for digital radiography examinations from patient search and entry, generator control,image acquisition and processing to DICOM data archiving and export. Visaris Avanse® PACS can also include a number of Digital Radiology modules such as network DICOM archive (PACS module), DICOM modality worklist module and diagnostic workstation software to turn it into digital radiology department on a PC for small clinics. Visaris Avanse ® is autonomous software and involves no hardware. It runs under the MS Windows XP/7/8 operating system on any hardware platform meeting the minimum system requirements.

VISARIS DOO

Radiological PACS software

• Primary Device ID: 08606102809033
• NIH Device Record Key: 4c04c237-a24e-4816-baaa-d727515b6a80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visaris Avanse
• Version Model Number: Avanse DR
• Company DUNS: 565466828
• Company Name: VISARIS DOO
• 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: false
• 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: +381112017678
• Email: support@visaris.com
• Phone: +381112017678
• Email: support@visaris.com
• Phone: +381112017678
• Email: support@visaris.com
• Phone: +381112017678
• Email: support@visaris.com
• Phone: +381112017678
• Email: support@visaris.com
• Phone: +381112017678
• Email: support@visaris.com
• Phone: +381112017678
• Email: support@visaris.com
• Phone: +381112017678
• Email: support@visaris.com
• Phone: +381112017678
• Email: support@visaris.com
• Phone: +381112017678
• Email: support@visaris.com
• Phone: +381112017678
• Email: support@visaris.com
• Phone: +381112017678
• Email: support@visaris.com
• Phone: +381112017678
• Email: support@visaris.com
• Phone: +381112017678
• Email: support@visaris.com
• Phone: +381112017678
• Email: support@visaris.com
• Phone: +381112017678
• Email: support@visaris.com
• Phone: +381112017678
• Email: support@visaris.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08606102809033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150725

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: 6
• Public Version Date: 2023-10-18
• Device Publish Date: 2016-10-11