FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Axial3D Insight
K Number: K250369
·
Decision Sep 18, 2025
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
5
Review Days
220
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Basic Information
- Device Name
- Axial3D Insight
- K Number
- K250369
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Axial Medical Printing Limited
- Date Received
- February 10, 2025
- Decision Date
- September 18, 2025
- 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 Axial Medical Printing Limited
| K Number | Device Name | ||
|---|---|---|---|
| K231607 | Axial3D Cloud Segmentation Service | Jan 24, 2024 | Substantially Equivalent |
| K232841 | Axial3D Insight | Nov 15, 2023 | Substantially Equivalent |
| K222745 | Axial3D Insight | Jul 3, 2023 | Substantially Equivalent |
| K221511 | Axial3D Cloud Segmentation Service | Jun 23, 2022 | Substantially Equivalent |