Advanced Visualization Workspace 881120

GUDID 00884838121553

Advanced Visualization Workspace is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing, archiving and filming of multimodality DICOM images. This software is for use with off-the-shelf hardware technology that meets defined minimum specifications.

Philips Medical Systems Nederland B.V.

Radiology DICOM image processing application software

• Primary Device ID: 00884838121553
• NIH Device Record Key: d0d6f1a0-3eaf-4c7e-ae3b-584a7c213359
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advanced Visualization Workspace
• Version Model Number: 15
• Catalog Number: 881120
• Company DUNS: 413819707
• Company Name: Philips Medical Systems Nederland B.V.
• 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

Customer Support Contacts

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838121553 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162025

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: 2023-08-15
• Device Publish Date: 2023-08-07

On-Brand Devices [Advanced Visualization Workspace]

• 00884838115613: Advanced Visualization Workspace is a software medical device that allows multiple users to remo
• 00884838121553: Advanced Visualization Workspace is a software medical device that allows multiple users to remo