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
- 21.x.y FDA UDI
- Description
- BriefCase is a radiological computer aided triage and notification software FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290018052259 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 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:
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 e3b63359-68d8-4037-9b2c-73d4a90113b0 34 fields · synced May 30, 2026