PIE MEDICAL IMAGING B.V.

FDA Device Registration & Listing · MAASTRICHT Limburg, NL · Registration 9710122

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9710122
FEI Number
3003595527
Entity Name
PIE MEDICAL IMAGING B.V.
City/State/Country
MAASTRICHT Limburg, NL
Establishment Address
Demertdwarsstraat 8A01, MAASTRICHT Limburg 6227 AK, NL
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Pie Medical Imaging B.V. (Owner Number: 9045579)
Owner / Operator Contact Address
Demertdwarsstraat 8A01, Maastricht, NL-NOTA 6227 AK, NL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K180019
PMA Number
N/A

All Registered Proprietary Names

CAAS, CAASII, CAAS2000 CAAS Workstation Caas Qardia CAAS MR Solutions CAAS Workstation CAAS MR Solutions 3mensio Structural Heart 3mensio Workstation 3mensio Vascular CAAS Workstation

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2007-11-19
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2024-04-18
QHA X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device Radiology Class 2 892.1600 2024-04-18
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2022-06-20
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2024-02-05
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2016-04-07
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2016-04-07
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2018-12-12
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2016-07-04
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2018-05-23
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2018-05-23

Official Correspondent

Annemiek Bouts

US Agent Details

Yong Sun Business: EMERGO GLOBAL REPRESENTATION LLC Email: USAgent@UL.com Phone: (512) 3279997

Related Public Records

Same Entity

Pie Medical Imaging B.V.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K080013 Agfa Healthcare Corporation REGISTRATION AND FUSION 2008-01-17
K042221 Barco NV Barcoview CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM 2004-12-30
K092915 Cedara Software Corp. CEDARA WEBACCESS, MODEL: 2.4 2010-06-23
K961871 Siemens Medical Solutions USA, Inc. FLOUROSPOT T.O.P. 1996-07-31
K122260 Aycan Digitalsysteme GmbH AYCAN MOBILE 2012-09-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0012-2022 GE Healthcare, LLC 2
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016 GE Healthcare 2
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026 CHANGE HEALTHCARE CANADA COMPANY 2
Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012 Philips Healthcare Inc. 2
MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007 AGFA Corp. 2
IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710122. Last updated year: 2026. Please use registration number 9710122 when referencing this establishment in official correspondence.
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