FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
EOSedge
K Number: K233920
·
Decision Aug 6, 2024
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
347
Applicant Total
7
Review Days
237
Basic Information
- Device Name
- EOSedge
- K Number
- K233920
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- EOS imaging
- Date Received
- December 13, 2023
- Decision Date
- August 6, 2024
- Product Code
- KPR
- 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 |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | FDA class 2 | Radiology |
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Other Clearances by EOS imaging
| K Number | Device Name | ||
|---|---|---|---|
| K240582 | VEA Align; spineEOS | Jun 25, 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 |