IntelliSpace Cardiovascular 98960612483X

GUDID 00884838087460

Cardiovascular Image and Information Management Solution (CVIS)

Philips Medical Systems Nederland B.V.

Radiology picture archiving and communication system workstation

• Primary Device ID: 00884838087460
• NIH Device Record Key: d52732fb-919c-4988-a3d5-15ef326b8799
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IntelliSpace Cardiovascular
• Version Model Number: 3.1
• Catalog Number: 98960612483X
• 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
• 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	00884838087460 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153022

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: 2019-01-17
• Device Publish Date: 2018-03-30

On-Brand Devices [IntelliSpace Cardiovascular]

• 00884838091429: Cardiovascular Image and Information Management Solution (CVIS)
• 00884838087460: Cardiovascular Image and Information Management Solution (CVIS)
• 00884838085770: Cardiovascular Image and Information Management Solution (CVIS)
• 00884838085220: Cardiovascular Image and Information Management Solution (CVIS)
• 00884838076730: Cardiovascular Image and Information Management Solution (CVIS)
• 00884838075214: Cardiovascular Image and Information Management Solution (CVIS)
• 00884838093072: Cardiovascular Image and Information Management Solution (CVIS)
• 00884838095250: Cardiovascular Image and Information Management Solution (CVIS)
• 00884838106970: Cardiovascular Image and Information Management Solution (CVIS)
• 00884838115378: Cardiovascular Image and Information Management Solution (CVIS)
• 00884838100107: Cardiovascular Image and Information Management Solution (CVIS)
• 00884838122000: IntelliSpace Cardiovascular is a comprehensive cardiac image and information management solution