Computerized Cognitive Assessment Aid
The Computerized Cognitive Assessment Aid (product code PKQ) is a Class 2 neurology device that provides clinicians in healthcare settings with objective measurements of cognitive function as a screening aid for adults aged 55 and older. It is regulated under 882.1470 and requires 510(k) clearance; its intended purposes include identifying potential cognitive decline relative to age-normal baselines, referring patients for further testing, and monitoring changes over time. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PKQ
- Device Class
- FDA class 2
- Regulation Number
- 882.1470
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Definition
The computerized cognitive assessment aid provides clinicians in a healthcare setting with objective measurements of cognitive function as a screening aid in the assessment of adults 55 years of age and older. This is done for the purpose of identifying a potential decline in cognitive function relative to baseline test performance of other age-normal adults, referring those adults for further testing where warranted, and monitoring changes in cognitive function over time
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K161328 | Cantab Mobile | Jan 13, 2017 | Substantially Equivalent | Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd. |
| K150154 | ANAM Test System: Military Battery | Aug 28, 2015 | Substantially Equivalent | Vista Lifesciences, Inc. |
| DEN130033 | COGNIVUE | Jun 05, 2015 | Unknown | Cerebral Assessment Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.