FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
icobrain aria
K Number: K240712
·
Decision Nov 7, 2024
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
9
Applicant Total
4
Review Days
237
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Basic Information
- Device Name
- icobrain aria
- K Number
- K240712
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2090
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Icometrix NV
- Date Received
- March 15, 2024
- Decision Date
- November 7, 2024
- Product Code
- QBS
- 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 |
|---|---|---|---|
| QBS | Radiological Computer Assisted Detection/Diagnosis Software For Fracture | FDA class 2 | Radiology |
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