Vue PACS 8986424

GUDID 00884838100336

The Vue PACS is an image management system whose intended use is to provide completely scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. The system is to be used by trained professionals including, but not limited to, physicians and medical technicians.

Philips Medical Systems Nederland B.V.

Radiology PACS software

• Primary Device ID: 00884838100336
• NIH Device Record Key: c8e36163-b544-49b1-b16d-e2058805e3f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vue PACS
• Version Model Number: 12
• Catalog Number: 8986424
• 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	00884838100336 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110919

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: 2020-05-26
• Device Publish Date: 2020-05-18

Devices Manufactured by Philips Medical Systems Nederland B.V.

• 00884838125940 - IntelliSpace Clinical Applications: 2024-11-11 IntelliSpace Clinical Applications is an image processing workstation software package designed to run on standard PC hardware.
• 00884838121270 - Philips IntelliSite Pathology Solution: 2024-10-16 Whole Slide Imaging System. The device is an automated digital slide creation, viewing and management system.
• 00884838118454 - Philips: 2024-07-26 MRI Needle Block 8G
• 00884838118461 - Philips: 2024-07-26 Fiducial Marker Sleeve Assembly
• 00884838118478 - Philips: 2024-07-26 FIDUCIAL MARKER GRID BLOCK ASSEMBLY
• 00884838118485 - Philips: 2024-07-26 MRI Needle Block 12G
• 00884838118492 - Philips: 2024-07-26 MRI Needle Block 14G
• 00884838118508 - Philips: 2024-07-26 MRI Needle Block 16G