FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
X-MIND Trium
K Number: K191719
·
Decision Feb 20, 2020
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
5
Review Days
239
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Basic Information
- Device Name
- X-MIND Trium
- K Number
- K191719
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- De Gotzen S.R.L.
- Date Received
- June 26, 2019
- Decision Date
- February 20, 2020
- Product Code
- MUH
- 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 |
|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | FDA class 2 | Dental |
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Other Clearances by De Gotzen S.R.L.
| K Number | Device Name | ||
|---|---|---|---|
| K201382 | X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) | Nov 18, 2020 | Substantially Equivalent |
| K192165 | Acteon Imaging Suite | Feb 11, 2020 | Substantially Equivalent |
| K160166 | X-MIND trium | Nov 15, 2016 | Substantially Equivalent |
| K132378 | X-MIND UNITY | May 30, 2014 | Substantially Equivalent |