FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
3mensio Workstation
K Number: K250330
·
Decision Nov 3, 2025
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
23
Review Days
271
Basic Information
- Device Name
- 3mensio Workstation
- K Number
- K250330
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pie Medical Imaging BV
- Date Received
- February 5, 2025
- Decision Date
- November 3, 2025
- 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 Pie Medical Imaging BV
| K Number | Device Name | ||
|---|---|---|---|
| K232147 | CAAS Workstation | Apr 9, 2024 | Substantially Equivalent |
| K232007 | CAAS MR Solutions | Feb 1, 2024 | Substantially Equivalent |
| K212376 | Caas Qardia | May 16, 2022 | Substantially Equivalent |
| K181825 | CAAS MR Solutions | Dec 4, 2018 | Substantially Equivalent |
| K180019 | CAAS Workstation | May 3, 2018 | Substantially Equivalent |
| K162376 | CAAS MR 4D Flow | Dec 8, 2016 | Substantially Equivalent |
| K162112 | CAAS MRV | Sep 21, 2016 | Substantially Equivalent |
| K153736 | 3mensio Workstation | May 27, 2016 | Substantially Equivalent |
| K151780 | CAAS Workstation | Mar 11, 2016 | Substantially Equivalent |
| K143044 | CAAS A-Valve | Feb 6, 2015 | Substantially Equivalent |