INTELLISPACE™ COGNITION 821401000000

GUDID 00884838103535

Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare Professionals in assessing the cognition of individuals. It is a cloud-based Software as a Service consisting of both a patient interface on a tablet and a clinician interface that can be used on any PC or tablet. The patient uses a digital pencil on the tablet to complete a cognitive assessment. The application immediately scores the tests, compares to norms and displays the results in terms of cognitive domains as part of a comprehensive report.

Philips Electronics Nederland B.V.

Cognitive assessment software

• Primary Device ID: 00884838103535
• NIH Device Record Key: ec77cd38-1b94-4c7e-9d99-4afe40cfd343
• Commercial Distribution Discontinuation: 2020-10-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: INTELLISPACE™ COGNITION
• Version Model Number: 3.0.x.x
• Catalog Number: 821401000000
• Company DUNS: 404559718
• Company Name: Philips Electronics Nederland B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838103535 [Primary]

FDA Product Code

• PTY: Computerized Cognitive Assessment Aid, Exempt

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: 2020-10-09
• Device Publish Date: 2020-10-01

On-Brand Devices [INTELLISPACE™ COGNITION]

• 00884838098244: 1.1.X
• 00884838103535: Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare P
• 00884838103900: Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare P
• 00884838104587: Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare P
• 00884838108554: Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare P