Company ยท NL
Pie Medical Imaging BV
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2025. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (0 in 12 months)
2recalls (1 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 3, 2025 | K250330 | 3mensio Workstation Pie Medical Imaging BV, NL | QIH |
| Apr 9, 2024 | K232147 | CAAS Workstation Pie Medical Imaging BV, NL | QHA |
| Feb 1, 2024 | K232007 | CAAS MR Solutions Pie Medical Imaging BV, NL | LLZ |
| May 16, 2022 | K212376 | Caas Qardia Pie Medical Imaging BV, NL | LLZ |
| Dec 4, 2018 | K181825 | CAAS MR Solutions Pie Medical Imaging BV, NL | LLZ |
| May 3, 2018 | K180019 | CAAS Workstation Pie Medical Imaging BV, NL | IZI |
| Dec 8, 2016 | K162376 | CAAS MR 4D Flow Pie Medical Imaging BV, NL | LLZ |
| Sep 21, 2016 | K162112 | CAAS MRV Pie Medical Imaging BV, NL | LLZ |
| May 27, 2016 | K153736 | 3mensio Workstation Pie Medical Imaging BV, NL | LLZ |
| Mar 11, 2016 | K151780 | CAAS Workstation Pie Medical Imaging BV, NL | IZI |
| Feb 6, 2015 | K143044 | CAAS A-Valve Pie Medical Imaging BV, NL | LLZ |
| Mar 25, 2014 | K133993 | CAAS WORKSTATION Pie Medical Imaging, NL | IZI |
| Feb 6, 2013 | K123970 | CAAS INTRAVASCULAR Pie Medical Imaging BV, NL | LLZ |
| Apr 17, 2012 | K120367 | 3MENSIO WORKSTATION Pie Medical Imaging BV, NL | LLZ |
| Jan 30, 2012 | K113076 | CAAS A-VALVE Pie Medical Imaging BV, NL | LLZ |
| Apr 30, 2010 | K100292 | CAAS QVA 3D, CAAS QCA 3D Pie Medical Imaging BV, NL | LLZ |
| May 22, 2009 | K090155 | CAAS MR FLOW 1.0 Pie Medical Imaging BV, NL | LLZ |
| Nov 28, 2006 | K063344 | CAAS QCA 3D Pie Medical Imaging BV, NL | LLZ |
| Apr 19, 2006 | K060941 | CAAS MRV VERSION 3.0 Pie Medical Imaging BV | LLZ |
| Dec 30, 2005 | K052988 | CAAS Pie Medical Imaging BV, NL | LLZ |
| Jul 27, 2004 | K041682 | CAAS MRV Pie Medical Imaging BV, NL | LLZ |
| Mar 17, 2004 | K033920 | CAAS II RVA Pie Medical Imaging BV, NL | LLZ |
| Oct 1, 2002 | K021495 | QIVA Pie Medical Imaging BV | DQK |
| Oct 24, 2001 | K012475 | CAAS II QVA Pie Medical Imaging BV, NL | LLZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2026 | PIE Medical Imaging B.V. 3mensio Workstation (Vascular Fenestrated) software Open, Classified |
QIH | K250330 |
| Aug 12, 2025 | PIE Medical Imaging B.V. 3mensio Workstation (Vascular Fenestrated) software Open, Classified |
LLZ | K153736 |