510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PIE Medical Imaging B.V.

MAASTRICHT Limburg, NL

PIE MEDICAL IMAGING B.V. appears in FDA device records in MAASTRICHT Limburg, NL. FDA records list 24 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
24
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 24 510(k) clearances for PIE Medical Imaging B.V. between 2001 and 2025. The busiest year on record is 2016, with 4. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for PIE Medical Imaging B.V., by decision year
YearClearances
20011
20021
20042
20051
20062
20091
20101
20122
20131
20141
20151
20164
20182
20221
20242
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K2503303mensio WorkstationQIHSubstantially Equivalent
K232147CAAS WorkstationQHASubstantially Equivalent
K232007CAAS MR SolutionsLLZSubstantially Equivalent
K212376Caas QardiaLLZSubstantially Equivalent
K181825CAAS MR SolutionsLLZSubstantially Equivalent
K180019CAAS WorkstationIZISubstantially Equivalent
K162376CAAS MR 4D FlowLLZSubstantially Equivalent
K162112CAAS MRVLLZSubstantially Equivalent
K1537363mensio WorkstationLLZSubstantially Equivalent
K151780CAAS WorkstationIZISubstantially Equivalent
K143044CAAS A-ValveLLZSubstantially Equivalent
K133993CAAS WORKSTATIONIZISubstantially Equivalent
K123970CAAS INTRAVASCULARLLZSubstantially Equivalent
K1203673MENSIO WORKSTATIONLLZSubstantially Equivalent
K113076CAAS A-VALVELLZSubstantially Equivalent
K100292CAAS QVA 3D, CAAS QCA 3DLLZSubstantially Equivalent
K090155CAAS MR FLOW 1.0LLZSubstantially Equivalent
K063344CAAS QCA 3DLLZSubstantially Equivalent
K060941CAAS MRV VERSION 3.0LLZSubstantially Equivalent
K052988CAASLLZSubstantially Equivalent
K041682CAAS MRVLLZSubstantially Equivalent
K033920CAAS II RVALLZSubstantially Equivalent
K021495QIVADQKSubstantially Equivalent
K012475CAAS II QVALLZSubstantially Equivalent

Registered establishments

FDA registered establishments for PIE Medical Imaging B.V., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
97101223003595527PIE MEDICAL IMAGING B.V.Demertdwarsstraat 8A01, MAASTRICHT Limburg 6227 AK NL2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2767-20263mensio Workstation (Vascular Fenestrated) softwareUser 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 dataset containing Color Doppler informationClass IIOpen, Classified
Z-2297-20253mensio Workstation (Vascular Fenestrated) softwareWhen 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 blood flow disruption and tissue damageClass IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain