FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EOS
K Number: K123740
·
Decision Feb 22, 2013
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
15
Review Days
79
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Basic Information
- Device Name
- EOS
- K Number
- K123740
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Eos Imaging
- Date Received
- December 5, 2012
- Decision Date
- February 22, 2013
- Product Code
- MQB
- 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 |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 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 |
| 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 |
| K152788 | EOS System | Oct 21, 2015 | Substantially Equivalent |