IntelliSpace Cardiovascular 830089

GUDID 00884838122000

IntelliSpace Cardiovascular is a comprehensive cardiac image and information management solution designed to provide clinicians with convenient access to the detailed records of all cardiac patients across their complete cardiovascular care continuum. The application also provides hospital administrators and department managers with detailed operational information, as well as productivity and outcomes reporting. Key components include a wide range of detailed clinical modules that capture data during diagnostic/therapeutic procedures and patient follow–up encounters. Interfaces to other systems and devices within the cardiology departments as well as across the enterprise system, such as HIS/EMR, are available. The solution supports a remote deployment model.

Philips Medical Systems Nederland B.V.

Radiology picture archiving and communication system workstation

• Primary Device ID: 00884838122000
• NIH Device Record Key: d6b99f2f-0493-45f6-8e0b-625a411e90c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IntelliSpace Cardiovascular
• Version Model Number: 8
• Catalog Number: 830089
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838122000 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-08
• Device Publish Date: 2024-04-30

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