# Philips Medical Systems Nederland B.V.

- Location (FDA's records): Best Noord-Brabant, NL
- FDA decisions: 107 (2005–2026): 106 510(k) clearances and 1 De Novo grant
- Product codes: OWB (29), LNH (27), LLZ (17), JAK (8), PSY (7), MOS (6), DQK (4), QIH (2), KPS (2), BSP (1), OEO (1), IZI (1)
- 510(k) review time since 2016: median 81 days, against 107 for FDA's reviews in the same codes and years (46 of 77 faster)
- Predicates its devices cite: 155 (57 its own); citations of its devices by later devices: 114 (57 its own)
- Recalls linked to its devices: 489 (24 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Philips Medical Systems North America, Inc.: 25 (https://510kreport.com/company/philips-medical-systems-north-america)
- Philips Medical Systems (Cleveland), Inc.: 6 (https://510kreport.com/company/philips-medical-systems-cleveland)
- Philips Medical Systems Nethrlands BV: 5 (https://510kreport.com/company/philips-medical-systems-nethrlands)
- Philips Medical Systems, Inc.: 5 (https://510kreport.com/company/philips-medical-systems)
- GE Medical Systems: 5 (https://510kreport.com/company/ge-medical-systems)
- Siemens Medical Solutions USA, Inc.: 4 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Philips Health Care: 4 (https://510kreport.com/company/philips-health-care)
- Mri Devices Corp.: 4 (https://510kreport.com/company/mri-devices)

## Firms that cite its devices most
- Philips Medical Systems Nederlands B.V.: 7 (https://510kreport.com/company/philips-medical-systems-nederlands)
- Philips Medical Systems, Inc.: 4 (https://510kreport.com/company/philips-medical-systems)
- Canon Medical Systems Corporation: 3 (https://510kreport.com/company/canon-medical-systems)
- Philips Medical Systems Technologies, Ltd.: 3 (https://510kreport.com/company/philips-medical-systems-technologies)
- Paige.Ai, Inc.: 1 (https://510kreport.com/company/paige-ai)
- Allengers Medical Systems Limited: 1 (https://510kreport.com/company/allengers-medical-systems)
- Spintech, Inc.: 1 (https://510kreport.com/company/spintech)
- Inspirata, Inc.: 1 (https://510kreport.com/company/inspirata)

## Its most-cited devices
- DEN160056: Philips IntelliSite Pathology Solution (2017), cited by 9
- K162484: Lung Nodule Assessment and Comparison Option (LNA) (2017), cited by 6
- K193215: Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems (2020), cited by 6
- K163116: Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (2017), cited by 4
- K111245: Heartnavigator Release 1 (2011), cited by 4
- K121772: Allura 3D-RA Rel 6, 3D Roadmap Rel 1, MR-CT Roadmap Rel 1 (2013), cited by 4

## Recent decisions
- K254205: Zenition 30 (Aug 7, 2026)
- K262330: dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T (Jul 30, 2026)
- K262294: dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T (Jul 24, 2026)
- K260207: Multimodality Simulation Workspace (MM Sim) (v1.0.0) (May 27, 2026)
- K253614: EchoNavigator R5.0 (Mar 17, 2026)
- K260169: AV Cardiac CT (Mar 5, 2026)
- K253648: Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades (Feb 23, 2026)
- K253735: AV Vascular (Jan 22, 2026)

Source page: https://510kreport.com/company/philips-medical-systems-nederland