# Philips Health Care

- Location (FDA's records): Bothell, WA
- FDA decisions: 20 (2011–2020): 20 510(k) clearances
- Product codes: IYN (7), LLZ (5), DQK (2), QIH (2), JAK (2), DPS (1), LNH (1)
- 510(k) review time since 2016: median 26 days, against 95 for FDA's reviews in the same codes and years (10 of 10 faster)
- Predicates its devices cite: 26 (7 its own); citations of its devices by later devices: 50 (7 its own)
- Recalls linked to its devices: 70 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Philips Ultrasound, Inc.: 10 (https://510kreport.com/company/philips-ultrasound)
- Philips Healthcare, Inc.: 1 (https://510kreport.com/company/philips-healthcare)
- Philips Medical Systems (Cleveland), Inc.: 1 (https://510kreport.com/company/philips-medical-systems-cleveland)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Philips Medical Systems, Inc.: 1 (https://510kreport.com/company/philips-medical-systems)
- Philips Medical Systems North America, Inc.: 1 (https://510kreport.com/company/philips-medical-systems-north-america)
- Philips Medical Systems Nederland B.V.: 1 (https://510kreport.com/company/philips-medical-systems-nederland)
- GE Medical Systems: 1 (https://510kreport.com/company/ge-medical-systems)

## Firms that cite its devices most
- Philips Ultrasound, Inc.: 19 (https://510kreport.com/company/philips-ultrasound)
- CHISON Medical Technologies Co., Ltd.: 5 (https://510kreport.com/company/chison-medical-technologies)
- Philips Medical Systems Nederland B.V.: 4 (https://510kreport.com/company/philips-medical-systems-nederland)
- Qisda Corporation: 2 (https://510kreport.com/company/qisda)
- Philips Medical Systems Nederlands B.V.: 1 (https://510kreport.com/company/philips-medical-systems-nederlands)
- Clear Guide Medical: 1 (https://510kreport.com/company/clear-guide-medical)
- Medo.Ai: 1 (https://510kreport.com/company/medo-ai)
- Cycle Clarity: 1 (https://510kreport.com/company/cycle-clarity)

## Its most-cited devices
- K192226: Lumify Diagnostic Ultrasound System (2019), cited by 9
- K110151: Achieva R4 1.5T and Achieva R4 3.0T (2011), cited by 8
- K191647: QLAB Advanced Quantification Software (2019), cited by 6
- K162329: CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System (2016), cited by 6
- K162549: Lumify Ultrasound System (2016), cited by 4
- K120321: Clearvue 350/550 Diagnostic Ultrasound System (2012), cited by 3

## Recent decisions
- K201352: 3D Auto LAA (Aug 17, 2020)
- K200974: QLAB Advanced Quantification Software (Jun 3, 2020)
- K200179: Collaboration Live (Feb 18, 2020)
- K191647: QLAB Advanced Quantification Software (Dec 20, 2019)
- K192226: Lumify Diagnostic Ultrasound System (Sep 6, 2019)
- K190913: QLAB Advanced Quantification Software 13 (Jun 18, 2019)
- K172607: Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System (Oct 4, 2017)
- K171314: QLAB Advanced Quantification Software (May 30, 2017)

Source page: https://510kreport.com/company/philips-health-care