FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
Transpara Density 1.0.0
K Number: K232096
·
Decision Dec 11, 2023
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
7
Review Days
151
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Basic Information
- Device Name
- Transpara Density 1.0.0
- K Number
- K232096
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Screenpoint Medical B.V.
- Date Received
- July 13, 2023
- Decision Date
- December 11, 2023
- 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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Other Clearances by Screenpoint Medical B.V.
| K Number | Device Name | ||
|---|---|---|---|
| K241831 | Transpara (2.1.0) | Nov 25, 2024 | Substantially Equivalent |
| K221347 | Transpara 1.7.2 | Aug 3, 2022 | Substantially Equivalent |
| K210404 | Transpara 1.7.0 | Jun 2, 2021 | Substantially Equivalent |
| K193229 | Transpara | Mar 5, 2020 | Substantially Equivalent |
| K192287 | Transpara | Dec 10, 2019 | Substantially Equivalent |
| K181704 | Transpara | Nov 21, 2018 | Substantially Equivalent |