IntelliSpace Cardiovascular 830089

GUDID 00884838095250

Cardiovascular Image and Information Management Solution (CVIS)

Philips Medical Systems Nederland B.V.

Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation

• Primary Device ID: 00884838095250
• NIH Device Record Key: 5d8b8a56-8754-4ed0-84e1-7ff2e8f2f774
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IntelliSpace Cardiovascular
• Version Model Number: 4.2
• 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
• 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	00884838095250 [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: 2
• Public Version Date: 2020-01-22
• Device Publish Date: 2019-11-15

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)