Medical Device Manufacturer · NL , Maastricht

Pie Medical Imaging BV - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 2001
23
Total
23
Cleared
0
Denied

FDA 510(k) cleared devices by Pie Medical Imaging BV Radiology

22 devices
1-22 of 22
Cleared Nov 03, 2025
3mensio Workstation
K250330 · QIH
Radiology · 271d
Cleared Apr 09, 2024
CAAS Workstation
K232147 · QHA
Radiology · 265d
Cleared Feb 01, 2024
CAAS MR Solutions
K232007 · LLZ
Radiology · 210d
Cleared May 16, 2022
Caas Qardia
K212376 · LLZ
Radiology · 290d
Cleared Dec 04, 2018
CAAS MR Solutions
K181825 · LLZ
Radiology · 148d
Cleared May 03, 2018
CAAS Workstation
K180019 · IZI
Radiology · 121d
Cleared Dec 08, 2016
CAAS MR 4D Flow
K162376 · LLZ
Radiology · 106d
Cleared Sep 21, 2016
CAAS MRV
K162112 · LLZ
Radiology · 54d
Cleared May 27, 2016
3mensio Workstation
K153736 · LLZ
Radiology · 151d
Cleared Mar 11, 2016
CAAS Workstation
K151780 · IZI
Radiology · 254d
Cleared Feb 06, 2015
CAAS A-Valve
K143044 · LLZ
Radiology · 107d
Cleared Feb 06, 2013
CAAS INTRAVASCULAR
K123970 · LLZ
Radiology · 42d
Cleared Apr 17, 2012
3MENSIO WORKSTATION
K120367 · LLZ
Radiology · 71d
Cleared Jan 30, 2012
CAAS A-VALVE
K113076 · LLZ
Radiology · 105d
Cleared Apr 30, 2010
CAAS QVA 3D, CAAS QCA 3D
K100292 · LLZ
Radiology · 87d
Cleared May 22, 2009
CAAS MR FLOW 1.0
K090155 · LLZ
Radiology · 120d
Cleared Nov 28, 2006
CAAS QCA 3D
K063344 · LLZ
Radiology · 22d
Cleared Apr 19, 2006
CAAS MRV VERSION 3.0
K060941 · LLZ
Radiology · 13d
Cleared Dec 30, 2005
CAAS
K052988 · LLZ
Radiology · 67d
Cleared Jul 27, 2004
CAAS MRV
K041682 · LLZ
Radiology · 36d
Cleared Mar 17, 2004
CAAS II RVA
K033920 · LLZ
Radiology · 90d
Cleared Oct 24, 2001
CAAS II QVA
K012475 · LLZ
Radiology · 83d
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