Neurotrack Cognitive Assessment Battery
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,…
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.
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Bestcovered Limited | Shanghai | Shanghai | Manufacturer | 2 |
| Yiwei Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
Record
| Listed by | Neurotrack Technologies, United States |
|---|---|
| FDA product code | PTY |
| Device type | Computerized Cognitive Assessment Aid, Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1470 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1.1.0 | In distribution |
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| DCTclock | Linus Health, Inc. | 11 |
| Intellispace™ Cognition | Philips Electronics Nederland B.V. | 6 |
| NeuroCatch Platform | NeuroCatch Inc. | 4 |
| Cognigram | Cogstate Ltd | 4 |
| NeuroCatch EEG Cap | NeuroCatch Inc. | 4 |
| Core Cognitive Evaluation | Linus Health, Inc. | 2 |
| Floodlight MS Cognitive Test | Roche Molecular Systems, Inc. | 2 |
| VRCogni | XR Health IL Ltd | 2 |
| Cognivue Clarity | Cognivue, Inc. | 2 |
| Cognivue Thrive | Cognivue, Inc. | 2 |
| Speech Vitals – Cognition | Aural Analytics, Inc. | 2 |
| Mspt Web v3.0 | Qr8 Health Inc | 1 |
Showing 12 of 48. All products under Computerized Cognitive Assessment Aid, Exempt
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.