# Philips Medical Systems, Inc.

- Location (FDA's records): Andover, MA
- FDA decisions: 225 (1983–2026): 221 510(k) clearances and 4 original PMA approvals
- Names in FDA's records: Philips Medical Systems, Inc. (114); Philips Medical Systems (108); Philips Medical Systems B.V. (3)
- Product codes: MHX (32), MKJ (19), LNH (16), LLZ (14), IYE (11), MWI (10), DPS (9), JAK (8), OWB (8), DQA (8), IZI (6), MSX (6)
- 510(k) review time since 2016: median 153 days, against 149 for FDA's reviews in the same codes and years (7 of 16 faster)
- Predicates its devices cite: 379 (150 its own); citations of its devices by later devices: 503 (150 its own)
- Recalls linked to its devices: 452 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Hewlett-Packard Co.: 73 (https://510kreport.com/company/hewlett-packard)
- Agilent Technologies, Inc.: 44 (https://510kreport.com/company/agilent-technologies)
- Philips Medical Systems North America, Inc.: 16 (https://510kreport.com/company/philips-medical-systems-north-america)
- Philips Medizin Systeme Boeblingen GmbH: 11 (https://510kreport.com/company/philips-medizin-systeme-boeblingen)
- Philips Medical Systems (Cleveland), Inc.: 9 (https://510kreport.com/company/philips-medical-systems-cleveland)
- Agilent Technologies Deutschland GmbH: 8 (https://510kreport.com/company/agilent-technologies-deutschland)
- Philips Medizin Systeme Boblingen GmbH: 5 (https://510kreport.com/company/philips-medizin-systeme-boblingen)
- ZOLL Medical Corporation: 4 (https://510kreport.com/company/zoll-medical)

## Firms that cite its devices most
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN: 60 (https://510kreport.com/company/philips-medizinsysteme-boeblingen-cardiac-an)
- Philips Medizin Systeme Boeblingen GmbH: 59 (https://510kreport.com/company/philips-medizin-systeme-boeblingen)
- Philips Medical Systems North America, Inc.: 37 (https://510kreport.com/company/philips-medical-systems-north-america)
- Philips Medizin Systeme Boblingen GmbH: 27 (https://510kreport.com/company/philips-medizin-systeme-boblingen)
- Philips Medical Systems (Cleveland), Inc.: 7 (https://510kreport.com/company/philips-medical-systems-cleveland)
- Aed Battery Exchange, LLC: 6 (https://510kreport.com/company/aed-battery-exchange)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 5 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- Philips Medical Systems Nederland B.V.: 5 (https://510kreport.com/company/philips-medical-systems-nederland)

## Its most-cited devices
- K021778: Philips Component Compact Monitor, Release a.04, Model #M1275B (2002), cited by 31
- K030038: Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185 Opt C41 Wireless Bedside Adaptr (2003), cited by 29
- K040357: M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry Monitoring System II (2004), cited by 27
- K033513: Easi Ecg Algorithm (2004), cited by 19
- K033444: Philips Medical Systems, M3012A- Hemodynamic Extension to the Multi-Measurement Server (2003), cited by 13
- K982795: Philips Bucky Vision (1998), cited by 11

## Recent decisions
- K253670: SmartCT (R3.0 (L10)) (Jul 10, 2026)
- K254186: Azurion R3.1 (Jan 16, 2026)
- K251827: Azurion R3.1 (Oct 24, 2025)
- K212704: Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System (Sep 24, 2021)
- K211597: EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System (Sep 8, 2021)
- K210560: Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph (Jun 30, 2021)
- K191738: PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph (Sep 29, 2020)
- P180028: HeartStart FRx Defibrillator (May 11, 2020)

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