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Pie Medical Imaging B.V.: FDA-registered device maker in MAASTRICHT Limburg, Netherlands, 10 510(k) clearances

Name: Pie Medical Imaging B.V. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Pie Medical Imaging B.V. is registered with the FDA (registration 9710122) in MAASTRICHT Limburg, Netherlands. It lists 4 device types. The FDA files 10 510(k) clearances under its listings, the newest dated November 3, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9710122
FEI number: 3003595527
Address: Demertdwarsstraat 8A01, MAASTRICHT Limburg, Netherlands, 6227 AK
Owner or operator: Pie Medical Imaging B.V. (9045579)
Roles: Manufacturer
First device listed: November 19, 2007
Registered through: 2026
Brand names listed: 3mensio Structural Heart, 3mensio Vascular, 3mensio Workstation, CAAS MR Solutions, CAAS QCA 3D, CAAS QVA 3D, CAAS Workstation, CAAS, CAASII, CAAS2000 and more

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Angiographic	IZI	2	Manufacturer	accessdata.fda.gov
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device	QHA	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 3, 2025	K250330	3mensio Workstation	QIH	Substantially Equivalent	Pie Medical Imaging BV	accessdata.fda.gov
April 9, 2024	K232147	CAAS Workstation	QHA	Substantially Equivalent	Pie Medical Imaging BV	accessdata.fda.gov
February 1, 2024	K232007	CAAS MR Solutions	LLZ	Substantially Equivalent	Pie Medical Imaging BV	accessdata.fda.gov
May 16, 2022	K212376	Caas Qardia	LLZ	Substantially Equivalent	Pie Medical Imaging BV	accessdata.fda.gov
December 4, 2018	K181825	CAAS MR Solutions	LLZ	Substantially Equivalent	Pie Medical Imaging BV	accessdata.fda.gov
May 3, 2018	K180019	CAAS Workstation	IZI	Substantially Equivalent	Pie Medical Imaging BV	accessdata.fda.gov
May 27, 2016	K153736	3mensio Workstation	LLZ	Substantially Equivalent	Pie Medical Imaging BV	accessdata.fda.gov
March 11, 2016	K151780	CAAS Workstation	IZI	Substantially Equivalent	Pie Medical Imaging BV	accessdata.fda.gov
April 30, 2010	K100292	CAAS QVA 3D, CAAS QCA 3D	LLZ	Substantially Equivalent	Pie Medical Imaging BV	accessdata.fda.gov
December 30, 2005	K052988	CAAS	LLZ	Substantially Equivalent	Pie Medical Imaging BV	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 7, 2026	98930	Class II	Ongoing	3mensio Workstation (Vascular Fenestrated) software	User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical dimension, if all the following occur: affected software is used, and the user has access only to 3D Echo OR Mitral 3D Echo, and the dataset being analyzed is a Philips 3D echo data	accessdata.fda.gov
July 14, 2025	97307	Class II	Ongoing	3mensio Workstation (Vascular Fenestrated) software	When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular structures) and the 12h position of a single clock is changed, other clock measurements are not updated relative to the new 12h position which may cause stent graft fenestrations at incorrect position, which may lead to	accessdata.fda.gov

Compare with other makers

Updated July 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.