# Philips Ultrasound, Inc.

- Location (FDA's records): Bothell, WA
- FDA decisions: 78 (1985–2026): 78 510(k) clearances
- Names in FDA's records: Philips Ultrasound, Inc. (46); Philips Ultrasound, LLC (27); Philips Ultrasound (5)
- Product codes: IYN (52), LLZ (13), JAK (3), IYO (3), ITX (3), HGL (1), QIH (1), JOP (1)
- 510(k) review time since 2016: median 72 days, against 115 for FDA's reviews in the same codes and years (32 of 46 faster)
- Predicates its devices cite: 111 (59 its own); citations of its devices by later devices: 139 (59 its own)
- Recalls linked to its devices: 132 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Philips Health Care: 19 (https://510kreport.com/company/philips-health-care)
- Advanced Technology Laboratories, Inc.: 6 (https://510kreport.com/company/advanced-technology-laboratories)
- Supersonic Imagine: 3 (https://510kreport.com/company/supersonic-imagine)
- Tomtec Imaging Systems GmbH: 3 (https://510kreport.com/company/tomtec-imaging-systems)
- Medison America, Inc.: 3 (https://510kreport.com/company/medison-america)
- Philips Medical Systems North America, Inc.: 2 (https://510kreport.com/company/philips-medical-systems-north-america)
- Siemens Medical Solutions USA, Inc.: 2 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Philips Medical Systems, Inc.: 2 (https://510kreport.com/company/philips-medical-systems)

## Firms that cite its devices most
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 10 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- Philips Health Care: 10 (https://510kreport.com/company/philips-health-care)
- Supersonic Imagine: 6 (https://510kreport.com/company/supersonic-imagine)
- Sonoscape Company Limited: 6 (https://510kreport.com/company/sonoscape)
- Sonosite,Inc.: 4 (https://510kreport.com/company/sonosite)
- Samsung Medison Co., Ltd.: 4 (https://510kreport.com/company/samsung-medison)
- Teratech Corp.: 4 (https://510kreport.com/company/teratech)
- Ultrasonix Medical Corporation: 3 (https://510kreport.com/company/ultrasonix-medical)

## Its most-cited devices
- K093563: IU22 Ultrasound System and Transducers (2010), cited by 12
- K042540: Philips IU22 Ultrasound System (2004), cited by 12
- K132304: Epiq Diagnostic Ultrasound System (2013), cited by 12
- K062247: HD11 Diagnostic Ultrasound System (2006), cited by 8
- K240850: EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems (2024), cited by 6
- K030455: Boris Platform Diagnostic Ultrasound System (2003), cited by 6

## Recent decisions
- K262548: EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (Sep 25, 2026)
- K262311: Alturion Series Diagnostic Ultrasound System (Aug 4, 2026)
- K261211: Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System (Jul 27, 2026)
- K260667: Alturion Series Diagnostic Ultrasound System (Jun 29, 2026)
- K260680: EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems (May 27, 2026)
- K260123: EPIQ Series Diagnostic Ultrasound System (May 27, 2026)
- K252558: Lumify Diagnostic Ultrasound System (May 5, 2026)
- K253595: EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System (Mar 27, 2026)

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