Vue Motion 1017979

GUDID 00884838100367

The Vue Motion software program is used for patient management by clinicians in order to access and display patient data, medical reports, medical data, and medical images for diagnosis from different modalities including CR, DR, CT, MR, NM, ECG, and US. Vue Motion provides wireless and portable access to medical images for remote reading or referral purposes from web browsers including usage with validated mobile devices. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by FDA for mammography.

Philips Medical Systems Nederland B.V.

Radiology PACS software

• Primary Device ID: 00884838100367
• NIH Device Record Key: 1a96cdfd-a8bb-4469-b056-0d8b8ffcb6d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vue Motion
• Version Model Number: 12
• Catalog Number: 1017979
• 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	00884838100367 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151774

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.

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• 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