Intellispace™ Cognition

FDA UDI

Class II (US FDA UDI)

by Philips Electronics Nederland B.V.

Identity

Trade Name: INTELLISPACE™ COGNITION FDA UDI
Generic Name: Cognitive assessment software FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 6.0.x.x FDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: 821401000000 FDA UDI
Primary DI / UDI-DI: 00884838108554 FDA UDI
FDA Product Code: PTY FDA UDI
GMDN Term: Cognitive assessment software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1470 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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Single Use

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Implantable

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Contains Latex

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Prescription Use

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Over-the-Counter

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Convenience Kit

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Combination Product

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HCT/P

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Premarket Exempt

Yes

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Lot / Batch Number

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Serial Number

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Expiration Date

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Manufacturing Date

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Category: Cognitive assessment software

Intellispace™ Cognition by Philips Electronics Nederland B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Philips Electronics Nederland B.V.

Sources (1)

FDA UDI 62c0b99c-f22a-45c6-ac57-664fe3ec2238 34 fields · synced Jun 9, 2026