Pie Medical Imaging BV is one of 68 FDA 510(k) medical device manufacturers from Netherlands in the dataset, ranked by real submission volume.
Pie Medical Imaging BV - FDA 510(k) Cleared Devices
Recent clearances: 3mensio Workstation, CAAS Workstation, CAAS MR Solutions
23
Total
23
Cleared
0
Denied
Pie Medical Imaging BV has 23 FDA 510(k) cleared radiology devices. Based in Maastricht, NL.
Latest FDA clearance: Nov 2025. Active since 2001.
Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Pie Medical Imaging BV
23 devices
Cleared
Nov 03, 2025
3mensio Workstation
Radiology
271d
Cleared
Apr 09, 2024
CAAS Workstation
Radiology
265d
Cleared
Feb 01, 2024
CAAS MR Solutions
Radiology
210d
Cleared
May 16, 2022
Caas Qardia
Radiology
290d
Cleared
Dec 04, 2018
CAAS MR Solutions
Radiology
148d
Cleared
May 03, 2018
CAAS Workstation
Radiology
121d
Cleared
Dec 08, 2016
CAAS MR 4D Flow
Radiology
106d
Cleared
Sep 21, 2016
CAAS MRV
Radiology
54d
Cleared
May 27, 2016
3mensio Workstation
Radiology
151d
Cleared
Mar 11, 2016
CAAS Workstation
Radiology
254d
Cleared
Feb 06, 2015
CAAS A-Valve
Radiology
107d
Cleared
Feb 06, 2013
CAAS INTRAVASCULAR
Radiology
42d
Cleared
Apr 17, 2012
3MENSIO WORKSTATION
Radiology
71d
Cleared
Jan 30, 2012
CAAS A-VALVE
Radiology
105d
Cleared
Apr 30, 2010
CAAS QVA 3D, CAAS QCA 3D
Radiology
87d
Cleared
May 22, 2009
CAAS MR FLOW 1.0
Radiology
120d
Cleared
Nov 28, 2006
CAAS QCA 3D
Radiology
22d
Cleared
Apr 19, 2006
CAAS MRV VERSION 3.0
Radiology
13d
Cleared
Dec 30, 2005
CAAS
Radiology
67d
Cleared
Jul 27, 2004
CAAS MRV
Radiology
36d
Cleared
Mar 17, 2004
CAAS II RVA
Radiology
90d
Cleared
Oct 01, 2002
QIVA
Cardiovascular
145d
Cleared
Oct 24, 2001
CAAS II QVA
Radiology
83d