FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
Transpara (2.1.0)
K Number: K241831
·
Decision Nov 25, 2024
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
34
Applicant Total
7
Review Days
153
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Basic Information
- Device Name
- Transpara (2.1.0)
- K Number
- K241831
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2090
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Screenpoint Medical B.V.
- Date Received
- June 25, 2024
- Decision Date
- November 25, 2024
- Product Code
- QDQ
- 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 |
|---|---|---|---|
| QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | FDA class 2 | Radiology |
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Other Clearances by Screenpoint Medical B.V.
| K Number | Device Name | ||
|---|---|---|---|
| K232096 | Transpara Density 1.0.0 | Dec 11, 2023 | 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 |