FDA UDI
Not in Commercial Distribution
🇺🇸 United States
INTELLISPACE™ COGNITION
DI: 00884838103535
·
Model: 3.0.x.x
·
Philips Electronics Nederland B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- INTELLISPACE™ COGNITION
- Primary DI
- 00884838103535
- Version / Model
- 3.0.x.x
- Catalog Number
- 821401000000
- Company Name
- Philips Electronics Nederland B.V.
- Labeler DUNS
- 404559718
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-01
- Public Version
- 2
- Public Version Date
- 2021-01-29
- Public Version Status
- Update
- Public Device Record Key
- ec77cd38-1b94-4c7e-9d99-4afe40cfd343
- Distribution End Date
- 2020-12-04
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PTY | Computerized Cognitive Assessment Aid, Exempt | Neurology | 882.1470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63185 | Cognitive assessment software | A software program intended to be used to assess cognitive function (e.g., attention/concentration, memory) and/or to assist early detection/diagnosis of mild cognitive impairment or dementia, using cognitive tests in combination with patient demographic data. The tests are completed by the patient on an off-the-shelf computer/tablet/smartphone and test results are intended to be reviewed by a medical specialist and/or used for longitudinal analysis. It is not intended for real-time home-monitoring of dementia patients. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838103535 | GS1 |