# Sonosite,Inc.

- Location (FDA's records): Bothell, WA
- FDA decisions: 23 (1998–2011): 23 510(k) clearances
- Product codes: IYN (16), IYO (3), ITX (2), DSB (1), OMF (1)
- Predicates its devices cite: 61 (29 its own); citations of its devices by later devices: 76 (29 its own)
- Recalls linked to its devices: 24 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Advanced Technology Laboratories, Inc.: 11 (https://510kreport.com/company/advanced-technology-laboratories)
- Philips Ultrasound, Inc.: 4 (https://510kreport.com/company/philips-ultrasound)
- Siemens Medical Systems, Inc.: 3 (https://510kreport.com/company/siemens-medical-systems)
- General Electric Co.: 2 (https://510kreport.com/company/general-electric)
- Cardiodynamics International Corp.: 2 (https://510kreport.com/company/cardiodynamics-international)
- Dymax Corp: 2 (https://510kreport.com/company/dymax)
- GE Medical Systems: 2 (https://510kreport.com/company/ge-medical-systems)
- Atcor Medical: 1 (https://510kreport.com/company/atcor-medical)

## Firms that cite its devices most
- Bard Access Systems, Inc.: 6 (https://510kreport.com/company/bard-access-systems)
- FUJIFILM Sonosite, Inc.: 4 (https://510kreport.com/company/fujifilm-sonosite)
- Ultrasonix Medical Corporation: 3 (https://510kreport.com/company/ultrasonix-medical)
- Toshibamedical Systems Corporation: 3 (https://510kreport.com/company/toshibamedical-systems)
- Teratech Corp.: 3 (https://510kreport.com/company/teratech)
- GE Healthcare: 2 (https://510kreport.com/company/ge-healthcare)
- Esaote Europe B.V.: 2 (https://510kreport.com/company/esaote-europe)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 2 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)

## Its most-cited devices
- K053069: Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) (2005), cited by 13
- K082098: Sonosite Maxx Series Ultrasound System (2008), cited by 7
- K113156: Sonosite Edge Ultrasound System (2011), cited by 6
- K014116: Hand-Carried Ultrasound System (2001), cited by 6
- K071134: Sonosite Maxx Series Diagnostic Ultrasound System (2007), cited by 6
- K043559: Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series) (2005), cited by 5

## Recent decisions
- K113156: Sonosite Edge Ultrasound System (Nov 15, 2011)
- K110645: Bio Z Cardio Profile Hemodynamic Monitor (Jun 3, 2011)
- K102390: Sonosite Nanomaxx Series Ultrasound System (Nov 19, 2010)
- K093510: Lumenvu Catheter Guidance System (Aug 23, 2010)
- K101757: Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound System (Aug 12, 2010)
- K092058: Sonosite Nanomaxx Series Ultrasound System (Oct 2, 2009)
- K082098: Sonosite Maxx Series Ultrasound System (Aug 25, 2008)
- K071134: Sonosite Maxx Series Diagnostic Ultrasound System (May 8, 2007)

Source page: https://510kreport.com/company/sonosite