FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)
K Number: K231055
·
Decision Dec 28, 2023
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
189
Applicant Total
2
Review Days
259
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Basic Information
- Device Name
- x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)
- K Number
- K231055
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- De Götzen S.R.L.
- Date Received
- April 13, 2023
- Decision Date
- December 28, 2023
- Product Code
- EHD
- Advisory Committee
- Dental
- 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 |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | FDA class 2 | Dental |
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Other Clearances by De Götzen S.R.L.
| K Number | Device Name | ||
|---|---|---|---|
| K203374 | X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) | Feb 5, 2021 | Substantially Equivalent |