Identity
- Trade Name
- InferRead CT Stroke.AI FDA UDI
- Generic Name
- Diagnostic x-ray digital imaging system workstation FDA UDI
- Device Name
- InferRead CT Stroke.AI is a radiological computer aided triage and notification software for use in the analysis of non-enhanced head CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging suspected positive findings of intracranial hemorrhage (ICH). FDA UDI
- Model / Reference
- 1.1.0.0 FDA UDI
- Description
- InferRead CT Stroke.AI is a radiological computer aided triage and notification software for use in the analysis of non-enhanced head CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging suspected positive findings of intracranial hemorrhage (ICH). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850003095011 FDA UDI
- 510(k) Number
- K211179 FDA UDI
- FDA Product Code
- QAS FDA UDI
- GMDN Term
- Diagnostic x-ray digital imaging system workstation FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2080 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
Yes
FDA UDI
Category: Diagnostic x-ray digital imaging system workstationX-ray image interpretive software
InferRead CT Stroke.AI by Infervision US Inc — 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
- Infervision US Inc
Sources (1)
- FDA UDI 2db679d5-9fbe-403d-9286-3997c0298c17 34 fields · synced May 30, 2026