FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
DTX Studio Assist
K Number: K252086
·
Decision Nov 17, 2025
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
36
Applicant Total
1
Review Days
138
Basic Information
- Device Name
- DTX Studio Assist
- K Number
- K252086
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2070
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nobel Biocare C/O Medicim NV
- Date Received
- July 2, 2025
- Decision Date
- November 17, 2025
- Product Code
- MYN
- 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 |
|---|---|---|---|
| MYN | Analyzer, Medical Image | FDA class 2 | Radiology |
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