FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Ez3D-i /E3
K Number: K231757
·
Decision Jul 14, 2023
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
31
Review Days
28
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Basic Information
- Device Name
- Ez3D-i /E3
- K Number
- K231757
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ewoosoft Co., Ltd.
- Date Received
- June 16, 2023
- Decision Date
- July 14, 2023
- 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 Ewoosoft Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K250005 | Clever One | May 23, 2025 | Substantially Equivalent |
| K241114 | EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) | Jul 23, 2024 | Substantially Equivalent |
| K230468 | EzDent Web | Apr 21, 2023 | Substantially Equivalent |
| K223820 | EzDent-i / E2 / Prora View/ Smart M Viewer | Feb 17, 2023 | Substantially Equivalent |
| K222069 | Ez3D-i/E3 | Sep 6, 2022 | Substantially Equivalent |
| K222145 | EzDent-i / E2 / Prora View/ Smart M Viewer | Aug 12, 2022 | Substantially Equivalent |
| K220003 | EzOrtho v1.3 | Feb 23, 2022 | Substantially Equivalent |
| K211795 | EzDent-i/ E2/ Prora View/ Smart M Viewer | Oct 4, 2021 | Substantially Equivalent |
| K211700 | EzDent Web | Sep 28, 2021 | Substantially Equivalent |
| K211793 | EzOrtho | Aug 23, 2021 | Substantially Equivalent |