PIE Medical Imaging B.V.
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 24
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2297-2025 | Class II | 3mensio Workstation (Vascular Fenestrated) software | July 14, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250330 | 3mensio Workstation | November 3, 2025 |
| K232147 | CAAS Workstation | April 9, 2024 |
| K232007 | CAAS MR Solutions | February 1, 2024 |
| K212376 | Caas Qardia | May 16, 2022 |
| K181825 | CAAS MR Solutions | December 4, 2018 |
| K180019 | CAAS Workstation | May 3, 2018 |
| K162376 | CAAS MR 4D Flow | December 8, 2016 |
| K162112 | CAAS MRV | September 21, 2016 |
| K153736 | 3mensio Workstation | May 27, 2016 |
| K151780 | CAAS Workstation | March 11, 2016 |
| K143044 | CAAS A-Valve | February 6, 2015 |
| K133993 | CAAS WORKSTATION | March 25, 2014 |
| K123970 | CAAS INTRAVASCULAR | February 6, 2013 |
| K120367 | 3MENSIO WORKSTATION | April 17, 2012 |
| K113076 | CAAS A-VALVE | January 30, 2012 |
| K100292 | CAAS QVA 3D, CAAS QCA 3D | April 30, 2010 |
| K090155 | CAAS MR FLOW 1.0 | May 22, 2009 |
| K063344 | CAAS QCA 3D | November 28, 2006 |
| K060941 | CAAS MRV VERSION 3.0 | April 19, 2006 |
| K052988 | CAAS | December 30, 2005 |