IntelliSpace Clinical Applications 837509

GUDID 00884838125940

IntelliSpace Clinical Applications is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. IntelliSpace Clinical Applications software receives image data from medical scanning devices, such as, but not limited to, CT and MRI, or from image archives. IntelliSpace Clinical Applications performs viewing, image manipulation, communication, printing, and quantification of images.

Philips Medical Systems Nederland B.V.

Radiology picture archiving and communication system workstation

• Primary Device ID: 00884838125940
• NIH Device Record Key: 79e40d42-4105-47a5-8ae8-051b3ffeac28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IntelliSpace Clinical Applications
• Version Model Number: 8.2.X
• Catalog Number: 837509
• 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(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838125940 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032096

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: 2024-11-11
• Device Publish Date: 2024-11-01

On-Brand Devices [IntelliSpace Clinical Applications]

• 00884838074804: Philips IntelliSpace Clinical Applications is an image processing workstation software package d
• 00884838125940: IntelliSpace Clinical Applications is an image processing workstation software package designed