Identity
- Trade Name
- BriefCase for ICH, PE and CSF triage FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- BriefCase is a radiological computer aided triage and notification software device. The device contains the software platform and image analysis algorithms for ICH, PE and CSF triage. FDA UDI
- Model / Reference
- 3.0.0 FDA UDI
- Description
- BriefCase is a radiological computer aided triage and notification software device. The device contains the software platform and image analysis algorithms for ICH, PE and CSF triage. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290018052044 FDA UDI
- FDA Product Code
- QAS FDA UDI
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2080 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
BriefCase for ICH, PE and CSF triage by Aidoc Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Aidoc Medical Ltd
Sources (1)
- FDA UDI ff074f1a-4755-4756-806e-07b43ef4269d 34 fields · synced May 31, 2026