FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
BriefCase-Triage
K Number: K251195
·
Decision Jan 27, 2026
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
85
Applicant Total
35
Review Days
285
Basic Information
- Device Name
- BriefCase-Triage
- K Number
- K251195
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2080
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aidoc Medical , Ltd.
- Date Received
- April 17, 2025
- Decision Date
- January 27, 2026
- Product Code
- QAS
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QAS | Radiological Computer-Assisted Triage And Notification Software | FDA class 2 | Radiology |
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Other Clearances by Aidoc Medical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K261317 | BriefCase-Triage | May 14, 2026 | Substantially Equivalent |
| K253578 | BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device | Feb 26, 2026 | Substantially Equivalent |
| K252970 | BriefCase-Triage: CARE Multi-triage CT Body | Jan 7, 2026 | Substantially Equivalent |
| K253265 | BriefCase-Triage | Nov 6, 2025 | Substantially Equivalent |
| K251406 | BriefCase-Triage | May 30, 2025 | Substantially Equivalent |
| K250248 | BriefCase-Triage | Feb 14, 2025 | Substantially Equivalent |
| K243548 | BriefCase-Triage | Dec 11, 2024 | Substantially Equivalent |
| K242203 | BriefCase-Quantification | Nov 22, 2024 | Substantially Equivalent |
| K242837 | BriefCase-Triage | Oct 18, 2024 | Substantially Equivalent |
| K241727 | BriefCase-Triage | Jul 12, 2024 | Substantially Equivalent |