INTELLISPACE™ COGNITION

GUDID 00884838101036

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 Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software Cognitive assessment software

• Primary Device ID: 00884838101036
• NIH Device Record Key: 23958ae6-d6ff-4ee5-a7aa-fcad221a99a2
• Commercial Distribution Discontinuation: 2020-09-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: INTELLISPACE™ COGNITION
• Version Model Number: 2.0.x.x
• 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	00884838101036 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-10-02
• Device Publish Date: 2020-05-19

Devices Manufactured by Philips Electronics Nederland B.V.

• 00884838108554 - INTELLISPACE™ COGNITION: 2021-10-12 Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare Professionals in assessing the co
• 00884838104587 - INTELLISPACE™ COGNITION: 2021-06-10 Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare Professionals in assessing the co
• 00884838103900 - INTELLISPACE™ COGNITION: 2021-02-05 Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare Professionals in assessing the co
• 00884838103535 - INTELLISPACE™ COGNITION: 2020-10-09 Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare Professionals in assessing the co
• 00884838101036 - INTELLISPACE™ COGNITION: 2020-10-02Philips 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.
• 00884838101036 - INTELLISPACE™ COGNITION: 2020-10-02 Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare Professionals in assessing the co
• 00884838098244 - INTELLISPACE™ COGNITION: 2019-11-07
• 00884838085640 - Philips IntelliSite Pathology Solution: 2019-04-23