FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
Customize
K Number: K213779
·
Decision Mar 16, 2022
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
3
Review Days
103
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Basic Information
- Device Name
- Customize
- K Number
- K213779
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3D-Side S.A.
- Date Received
- December 3, 2021
- Decision Date
- March 16, 2022
- Product Code
- QIH
- 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 |
|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | FDA class 2 | Radiology |
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