Identity
- Trade Name
- StrokeViewer Perfusion FDA UDI
- Generic Name
- X-ray image interpretive software FDA UDI
- Device Name
- StrokeViewer is an image processing software application that analyzes CT scans of the brain to provide quantitative perfusion information in brain tissue for suspected ischemic stroke patients. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- StrokeViewer is an image processing software application that analyzes CT scans of the brain to provide quantitative perfusion information in brain tissue for suspected ischemic stroke patients. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08720299502352 FDA UDI
- 510(k) Number
- K231570 FDA UDI
- FDA Product Code
- LLZ FDA UDIQAS FDA UDI
- GMDN Term
- X-ray image interpretive software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI892.2080 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: X-ray image interpretive software
StrokeViewer Perfusion by Nicolab B.V. — 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
- Nicolab B.V.
Sources (1)
- FDA UDI ba52c775-c1f6-4ea9-bf39-cf4c5d934982 34 fields · synced May 31, 2026