# Philips Medical Systems Nederlands B.V.

- Location (FDA's records): Best, NL
- FDA decisions: 8 (2015–2024): 8 510(k) clearances
- Product codes: LNH (3), OWB (3), LLZ (1), MWI (1)
- 510(k) review time since 2016: median 113 days, against 90 for FDA's reviews in the same codes and years (5 of 7 faster)
- Predicates its devices cite: 11 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Philips Medical Systems Nederland B.V.: 7 (https://510kreport.com/company/philips-medical-systems-nederland)
- Philips Health Care: 1 (https://510kreport.com/company/philips-health-care)
- GE Medical Systems: 1 (https://510kreport.com/company/ge-medical-systems)
- Witt Biomedical Corporation: 1 (https://510kreport.com/company/witt-biomedical)
- Orthovita, Inc.: 1 (https://510kreport.com/company/orthovita)

## Firms that cite its devices most
- Philips Medical Systems Nederland B.V.: 2 (https://510kreport.com/company/philips-medical-systems-nederland)
- Quantib B.V.: 1 (https://510kreport.com/company/quantib)

## Its most-cited devices
- K223442: MR 5300 and MR 7700 R11 MR Systems (2022), cited by 2
- K162025: IntelliSpace Portal Platform (2016), cited by 1

## Recent decisions
- K240224: Zenition 90 (May 22, 2024)
- K223442: MR 5300 and MR 7700 R11 MR Systems (Dec 23, 2022)
- K201743: ClarifEye R1.0, ClarifEye Needle (Feb 23, 2021)
- K181311: Philips Hemodynamic Application R1.0 (Sep 7, 2018)
- K181966: SmartPerfusion (Aug 17, 2018)
- K162025: IntelliSpace Portal Platform (Oct 18, 2016)
- K153324: Ingenia 1.5T and Ingenia 1.5T S R5.2 (Mar 22, 2016)
- K143128: mDIXON XD (Mar 20, 2015)

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