FDA UDI
In Commercial Distribution
🇺🇸 United States
StrokeViewer LVO Triaging
DI: 08720299502338
·
Model: 3
·
NICo-Lab B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- StrokeViewer LVO Triaging
- Primary DI
- 08720299502338
- Version / Model
- 3
- Company Name
- NICo-Lab B.V.
- Labeler DUNS
- 491812076
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-08
- Public Version
- 2
- Public Version Date
- 2022-05-12
- Public Version Status
- Update
- Public Device Record Key
- 82b2ff9c-a0b8-4072-b924-b2f7ad86db8a
Device Description
StrokeViewer LVO Triaging is a notification only cloud-based image processing software application using artificial intelligence algorithms to analyze patient imaging data in parallel to the standard of care imaging interpretation.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| QAS | Radiological Computer-Assisted Triage And Notification Software | Radiology | 892.2080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63386 | X-ray image interpretive software | An interpretive software program intended to be used to analyse non-dental x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It typically utilizes artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08720299502338 | GS1 |
Customer Contacts
- Phone
- +31202440852
- [email protected]