Identity
- Trade Name
- Neurotrack Cognitive Assessment Battery FDA UDI
- Generic Name
- Cognitive assessment software FDA UDI
- Device Name
- Neurotrack’s exam is a computerized cognitive exam delivered via mobile device or browser, intended to detect and track cognitive impairment in patients with existing cognitive impairment, subjective memory loss, or healthy individuals. The user will interact with the exam battery on a screen. Using visual cues, the user will touch the screen, trackpad or mouse to make a selection. Successful completion of the exam battery relies on use of the hands and eyes. The device may be used by the patient in the home, or in a health clinic with or without supervision. The results are reviewed by a health care provider trained in nervous system conditions. Neurotrack’s digital cognitive assessment suite is not a stand-alone diagnostic tool and does not identify the absence or presence of any illness, condition, or disease. While Neurotrack’s digital cognitive assessment suite can be self-administered, any interpretation of scores should be discussed with a healthcare provider. FDA UDI
- Model / Reference
- 1.1.0 FDA UDI
- Description
- Neurotrack’s exam is a computerized cognitive exam delivered via mobile device or browser, intended to detect and track cognitive impairment in patients with existing cognitive impairment, subjective memory loss, or healthy individuals. The user will interact with the exam battery on a screen. Using visual cues, the user will touch the screen, trackpad or mouse to make a selection. Successful completion of the exam battery relies on use of the hands and eyes. The device may be used by the patient in the home, or in a health clinic with or without supervision. The results are reviewed by a health care provider trained in nervous system conditions. Neurotrack’s digital cognitive assessment suite is not a stand-alone diagnostic tool and does not identify the absence or presence of any illness, condition, or disease. While Neurotrack’s digital cognitive assessment suite can be self-administered, any interpretation of scores should be discussed with a healthcare provider. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009484504 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cognitive assessment software
Neurotrack Cognitive Assessment Battery by Neurotrack Technologies — 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
- Neurotrack Technologies
Sources (1)
- FDA UDI b87e3e38-6f58-4d65-831f-eff82759fc29 33 fields · synced May 30, 2026