FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
BriefCase-Quantification
K Number: K230534
·
Decision Nov 8, 2023
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
35
Review Days
254
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Basic Information
- Device Name
- BriefCase-Quantification
- K Number
- K230534
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aidoc Medical , Ltd.
- Date Received
- February 27, 2023
- Decision Date
- November 8, 2023
- Product Code
- QIH
- 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 |
|---|---|---|---|
| QIH | Automated Radiological Image Processing 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 |
| K251195 | BriefCase-Triage | Jan 27, 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 |