# Philips Medical Systems North America, Inc.

- Location (FDA's records): Shelton, CT
- FDA decisions: 95 (1989–2010): 95 510(k) clearances
- Names in FDA's records: Philips Medical Systems North America, Inc. (71); Philips Medical Systems North America Co. (24)
- Product codes: LNH (19), LLZ (16), JAK (10), IZI (9), OWB (5), KPR (4), JAA (4), MHX (3), MOS (3), IZL (2), IYE (2), IZH (2)
- Predicates its devices cite: 110 (27 its own); citations of its devices by later devices: 156 (27 its own)
- Recalls linked to its devices: 309 (19 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Philips Medical Systems, Inc.: 37 (https://510kreport.com/company/philips-medical-systems)
- Philips Medizin Systeme Boeblingen GmbH: 16 (https://510kreport.com/company/philips-medizin-systeme-boeblingen)
- Siemens Medical Solutions USA, Inc.: 7 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Philips Medizin Systeme Boblingen GmbH: 6 (https://510kreport.com/company/philips-medizin-systeme-boblingen)
- GE Medical Systems: 4 (https://510kreport.com/company/ge-medical-systems)
- Masimo Corporation: 3 (https://510kreport.com/company/masimo)
- Siemens Medical Systems, Inc.: 2 (https://510kreport.com/company/siemens-medical-systems)
- Lorad Medical Systems, Inc.: 1 (https://510kreport.com/company/lorad-medical-systems)

## Firms that cite its devices most
- Philips Medical Systems Nederland B.V.: 25 (https://510kreport.com/company/philips-medical-systems-nederland)
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN: 23 (https://510kreport.com/company/philips-medizinsysteme-boeblingen-cardiac-an)
- Philips Medical Systems, Inc.: 16 (https://510kreport.com/company/philips-medical-systems)
- Philips Medizin Systeme Boeblingen GmbH: 10 (https://510kreport.com/company/philips-medizin-systeme-boeblingen)
- Philips Medical Systems Dmc GmbH: 5 (https://510kreport.com/company/philips-medical-systems-dmc)
- Philips Medizin Systeme Boblingen GmbH: 4 (https://510kreport.com/company/philips-medizin-systeme-boblingen)
- Omega Medical Imaging, Inc.: 4 (https://510kreport.com/company/omega-medical-imaging)
- Siemens Medical Solutions USA, Inc.: 3 (https://510kreport.com/company/siemens-medical-solutions-usa)

## Its most-cited devices
- K061052: The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90 (2006), cited by 20
- K062283: The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient Monitors (2006), cited by 18
- K984545: Release 2 of Philips Integris Series (V5000, BV5000, H5000, BH5000, HM2000) Systems (1999), cited by 8
- K090625: Wireless Portable Detector FD-W17 (2009), cited by 7
- K061995: Xcelera (2006), cited by 7
- K040254: Integris 3D-RA, Release 4.2 (2004), cited by 6

## Recent decisions
- K101311: EP Navigator R3 (Sep 30, 2010)
- K102005: Allura Xper or Table Series (Aug 9, 2010)
- K090625: Wireless Portable Detector FD-W17 (Mar 24, 2009)
- K090590: Veradius, Model 718-130 (Mar 16, 2009)
- K082280: Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor, Suresigns VS3 Cital Signs Monitor (Oct 8, 2008)
- K063781: Philips XD-S Direct Radiography Workstation/Package (Jan 5, 2007)
- K062233: Heartstart MRX Monitor/Defibrillator (Nov 22, 2006)
- K062268: Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03 (Oct 18, 2006)

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