FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
VisionX 3.0
K Number: K213326
·
Decision Nov 2, 2021
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
9
Review Days
28
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Basic Information
- Device Name
- VisionX 3.0
- K Number
- K213326
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Durr Dental SE
- Date Received
- October 5, 2021
- Decision Date
- November 2, 2021
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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|---|---|---|---|
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| K193139 | ProVecta 3D Prime Ceph | Mar 5, 2020 | Substantially Equivalent |
| K192743 | VisionX 2.4 | Oct 31, 2019 | Substantially Equivalent |
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| K181432 | ProVectra 3D Prime with VistaSoft | Aug 2, 2018 | Substantially Equivalent |