IntelliSpace Portal 45980163593X

GUDID 00884838093621

IntelliSpace Portal 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: 00884838093621
• NIH Device Record Key: cff27ce5-262e-4315-a997-66c3e59fb272
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IntelliSpace Portal
• Version Model Number: 12.x
• Catalog Number: 45980163593X
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838093621 [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: 2021-01-19
• Device Publish Date: 2021-01-11

On-Brand Devices [IntelliSpace Portal]

• 00884838086449: IntelliSpace Portal is a software medical device that allows multiple users to remotely access c
• 00884838083646: The IntelliSpace Portal V6.5 processes clinical images from a SBI* series that was generated by
• 00884838075894: IntelliSpace Portal is a software medical device that allows multiple users to remotely access c
• 00884838073876: IntelliSpace Portal is a software medical device that allows multiple users to remotely access c
• 00884838089808: IntelliSpace Portal is a software medical device that allows multiple users to remotely access c
• 00884838093621: IntelliSpace Portal is a software medical device that allows multiple users to remotely access c