Identity
- Trade Name
- BriefCase 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. Software version 2.0.0 for PE triage FDA UDI
- Model / Reference
- 2.0.0 FDA UDI
- Description
- BriefCase is a radiological computer aided triage and notification software device. Software version 2.0.0 for PE triage FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290018052020 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
BriefCase 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 690f89fd-70cd-4d11-84c3-7e3211b94dff 34 fields · synced May 30, 2026