Identity
- Trade Name
- BriefCase 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 FDA UDI
- Model / Reference
- 23.y.z FDA UDI
- Description
- BriefCase is a radiological computer aided triage and notification software FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290018052297 FDA UDI
- 510(k) Number
- K190896 FDA UDIK193298 FDA UDIK213721 FDA UDIK213886 FDA UDIK214043 FDA UDIK220709 FDA UDIK221240 FDA UDIK221314 FDA UDIK221330 FDA UDIK222277 FDA UDIK222329 FDA UDIK222692 FDA UDIK230020 FDA UDIK232751 FDA UDIK241727 FDA UDIK242837 FDA UDI
- FDA Product Code
- QAS FDA UDIQFM 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Radiology DICOM image processing application software
BriefCase Triage by Aidoc Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K190896 also covers:
K193298 also covers:
K213721 also covers:
K213886 also covers:
K214043 also covers:
K220709 also covers:
K221240 also covers:
K221314 also covers:
K221330 also covers:
K222277 also covers:
K222329 also covers:
K222692 also covers:
K230020 also covers:
K232751 also covers:
K241727 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
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 f67ed8b9-cdd9-4fa7-874d-810e1ff954d4 34 fields · synced May 30, 2026