IntelliSpace Portal

GUDID 00884838073876

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: 00884838073876
• NIH Device Record Key: 384dfd9a-c01a-476e-b0e1-9344f40613ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IntelliSpace Portal
• Version Model Number: 8.x
• 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

• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838073876 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060937

FDA Product Code

• JAK: System, x-ray, tomography, computed

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-09-24

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