# Pie Medical Imaging BV

- Location (FDA's records): Maastricht, NL
- FDA decisions: 24 (2001–2025): 24 510(k) clearances
- Names in FDA's records: Pie Medical Imaging BV (23); Pie Medical Imaging (1)
- Product codes: LLZ (18), IZI (3), QHA (1), DQK (1), QIH (1)
- 510(k) review time since 2016: median 151 days, against 105 for FDA's reviews in the same codes and years (1 of 7 faster)
- Predicates its devices cite: 43 (22 its own); citations of its devices by later devices: 46 (22 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medis Medical Imaging Systems BV: 6 (https://510kreport.com/company/medis-medical-imaging-systems)
- Pie Medical Equipment B.V.: 4 (https://510kreport.com/company/pie-medical-equipment)
- Paieon, Inc.: 3 (https://510kreport.com/company/paieon)
- Tomtec Imaging Systems GmbH: 2 (https://510kreport.com/company/tomtec-imaging-systems)
- Philips Medical Systems Nethrlands BV: 1 (https://510kreport.com/company/philips-medical-systems-nethrlands)
- Volcano Corporation: 1 (https://510kreport.com/company/volcano)
- Indec Systems, Inc.: 1 (https://510kreport.com/company/indec-systems)
- Medviso AB: 1 (https://510kreport.com/company/medviso)

## Firms that cite its devices most
- Paieon, Inc.: 3 (https://510kreport.com/company/paieon)
- Medis Medical Imaging Systems BV: 2 (https://510kreport.com/company/medis-medical-imaging-systems)
- Circle Cardiovascular Imaging, Inc.: 2 (https://510kreport.com/company/circle-cardiovascular-imaging)
- Hi-D Imaging AG: 1 (https://510kreport.com/company/hi-d-imaging)
- Shanghai United Imaging Healthcare Co., Ltd.: 1 (https://510kreport.com/company/shanghai-united-imaging-healthcare)
- Feops NV: 1 (https://510kreport.com/company/feops)
- Dyad Medical, Inc.: 1 (https://510kreport.com/company/dyad-medical)
- Terarecon,Inc.: 1 (https://510kreport.com/company/terarecon)

## Its most-cited devices
- K153736: 3mensio Workstation (2016), cited by 11
- K052988: CAAS (2005), cited by 8
- K120367: 3MENSIO Workstation (2012), cited by 4
- K180019: CAAS Workstation (2018), cited by 3
- K063344: Caas Qca 3D (2006), cited by 2
- K162376: CAAS MR 4D Flow (2016), cited by 2

## Recent decisions
- K250330: 3mensio Workstation (Nov 3, 2025)
- K232147: CAAS Workstation (Apr 9, 2024)
- K232007: CAAS MR Solutions (Feb 1, 2024)
- K212376: Caas Qardia (May 16, 2022)
- K181825: CAAS MR Solutions (Dec 4, 2018)
- K180019: CAAS Workstation (May 3, 2018)
- K162376: CAAS MR 4D Flow (Dec 8, 2016)
- K162112: Caas MRV (Sep 21, 2016)

Source page: https://510kreport.com/company/pie-medical-imaging