IntelliSpace Portal IX

GUDID 00884838083653

The IntelliSpace Portal IX V6.5 processes clinical images from a SBI* series that was generated by Philips IQon system and enables advanced visualization of the images. When used by qualified personnel, it provides useful diagnostic information. IntelliSpace Portal IX V6.5 can be used remotely by multiple users with compatible devices *SBI: Spectral Base Images. A set of dataset that are being used as the inputs for calculation of Spectral results that are being used for reading.

Philips Medical Systems Nederland B.V.

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• Primary Device ID: 00884838083653
• NIH Device Record Key: cc266351-9e05-49b0-b786-9befe72f4b57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IntelliSpace Portal IX
• Version Model Number: 6.5
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838083653 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150665

FDA Product Code

• LLZ: System, image processing, radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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