FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
BriefCase-Triage
K Number: K243548
·
Decision Dec 11, 2024
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
37
Applicant Total
30
Review Days
26
Basic Information
- Device Name
- BriefCase-Triage
- K Number
- K243548
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.2080
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aidoc Medical, Ltd.
- Date Received
- November 15, 2024
- Decision Date
- December 11, 2024
- Product Code
- QFM
- 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 |
|---|---|---|---|
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | FDA class 2 | Radiology |
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Other Clearances by Aidoc Medical, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K251406 | BriefCase-Triage | May 30, 2025 | Substantially Equivalent |
| K250248 | BriefCase-Triage | Feb 14, 2025 | 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 |
| K241112 | BriefCase-Quantification | May 15, 2024 | Substantially Equivalent |
| K231631 | BriefCase-Quantification | Nov 28, 2023 | Substantially Equivalent |
| K232083 | BriefCase-Quantification | Nov 13, 2023 | Substantially Equivalent |
| K230534 | BriefCase-Quantification | Nov 8, 2023 | Substantially Equivalent |
| K232751 | BriefCase-Triage | Oct 30, 2023 | Substantially Equivalent |