FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
BriefCase-Triage
K Number: K241727
·
Decision Jul 12, 2024
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
69
Applicant Total
30
Review Days
28
Basic Information
- Device Name
- BriefCase-Triage
- K Number
- K241727
- 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
- June 14, 2024
- Decision Date
- July 12, 2024
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QAS), ordered by most recent decision date.
Methinks NCCT Stroke
FDA 510(k)
FDA Class 2
·Radiology
BriefCase-Triage
FDA 510(k)
FDA Class 2
·Radiology
syngo.CT LVO Detection
FDA 510(k)
FDA Class 2
·Radiology
JLK-SDH
FDA 510(k)
FDA Class 2
·Radiology
EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
FDA 510(k)
FDA Class 2
·Radiology
BriefCase-Triage
FDA 510(k)
FDA Class 2
·Radiology
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 |
| K243548 | BriefCase-Triage | Dec 11, 2024 | Substantially Equivalent |
| K242203 | BriefCase-Quantification | Nov 22, 2024 | Substantially Equivalent |
| K242837 | BriefCase-Triage | Oct 18, 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 |