FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
VEA Align; spineEOS
K Number: K240582
·
Decision Jun 25, 2024
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
15
Review Days
116
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Basic Information
- Device Name
- VEA Align; spineEOS
- K Number
- K240582
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Eos Imaging
- Date Received
- March 1, 2024
- Decision Date
- June 25, 2024
- 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 Eos Imaging
| K Number | Device Name | ||
|---|---|---|---|
| K251078 | AutoDensity | Nov 14, 2025 | Substantially Equivalent |
| K251747 | VEA Align; spineEOS | Aug 15, 2025 | Substantially Equivalent |
| K233920 | EOSedge | Aug 6, 2024 | Substantially Equivalent |
| K231917 | VEA Align | Jan 5, 2024 | Substantially Equivalent |
| K232086 | spineEOS | Oct 24, 2023 | Substantially Equivalent |
| K202394 | EOSedge | Sep 16, 2020 | Substantially Equivalent |
| K192079 | EOSedge | Nov 27, 2019 | Substantially Equivalent |
| K172346 | sterEOS Workstation | Jun 19, 2018 | Substantially Equivalent |
| K152788 | EOS System | Oct 21, 2015 | Substantially Equivalent |
| K142773 | EOS System | Jan 22, 2015 | Substantially Equivalent |