FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
DTX Studio Clinic 3.0
K Number: K221921
·
Decision Mar 28, 2023
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
36
Applicant Total
92
Review Days
270
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Basic Information
- Device Name
- DTX Studio Clinic 3.0
- K Number
- K221921
- 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 AB
- Date Received
- July 1, 2022
- Decision Date
- March 28, 2023
- 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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