Anam Test System
The ANAM Test System is a software only device that provides clinicians with objective measurements of cognitive performance to aid in the assessment of an individual’s level of cognitive…
The ANAM Test System is a software only device that provides clinicians with objective measurements of cognitive performance to aid in the assessment of an individual’s level of cognitive performance. The ANAM Test System provides precise, objective, and repeatable automated measures of neurocognitive functions including response speed, attention/concentration, immediate and delayed memory, spatial processing, and decision processing speed and efficiency. It can be used to screen for general cognitive impairment within initial triage assessment/decision making or to obtain a more refined and detailed information regarding a person’s neurocognitive status. The battery is also specially designed for longitudinal assessment of cognitive functioning and can be used 1) to monitor progression of disease status; 2) to track cognitive change or recovery; and 3) to monitor the cognitive effects of medical interventions. The ANAM Test System provides both absolute and relative information about the test taker’s performance. Test performance following an injury, event, or intervention can be assessed by comparing a person’s test result to a previous testing point or to a pre-existing “baseline” if those data are available. If pre-existing testing data are unavailable, the ANAM Test System will provide a comparison of performance in relationship to a selected normative/reference group. The ANAM Performance Report software program will automatically provide comparisons to selectable reference groups as well as to the test taker’s previous testing data, if available.
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 | Vista Partners, LLC |
|---|---|
| FDA product code | PTY |
| Device type | Computerized Cognitive Assessment Aid, Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1470 |
| Premarket notification | Exempt |
| Record published | 2019-11-26 |
| Record revised | 2022-10-24 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4.5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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.