# FUJIFILM Sonosite, Inc.

- Location (FDA's records): Bothell, WA
- FDA decisions: 25 (2013–2026): 25 510(k) clearances
- Product codes: IYN (25)
- 510(k) review time since 2016: median 27 days, against 79 for FDA's reviews in the same codes and years (17 of 19 faster)
- Predicates its devices cite: 52 (45 its own); citations of its devices by later devices: 52 (45 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sonosite,Inc.: 4 (https://510kreport.com/company/sonosite)
- Philips Ultrasound, Inc.: 1 (https://510kreport.com/company/philips-ultrasound)
- Teratech Corp.: 1 (https://510kreport.com/company/teratech)
- Longport, Inc.: 1 (https://510kreport.com/company/longport)

## Firms that cite its devices most
- Clarius Mobile Health Corp.: 2 (https://510kreport.com/company/clarius-mobile-health)
- Kolo Medical (Suzhou) Co., Ltd.: 1 (https://510kreport.com/company/kolo-medical-suzhou)
- Samsung Medison Co., Ltd.: 1 (https://510kreport.com/company/samsung-medison)
- Imsonic Medical China, Inc.: 1 (https://510kreport.com/company/imsonic-medical-china)
- Linkquest, Inc.: 1 (https://510kreport.com/company/linkquest)
- Shenzhen Wisonic Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-wisonic-medical-technology)

## Its most-cited devices
- K133454: Sonosite Edge Ultrasound System (2013), cited by 11
- K162045: SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System (2016), cited by 7
- K130173: Sonosite Maxx Series Ultrasound System (2013), cited by 4
- K152209: FUJIFILM SonoSite X-Porte Ultrasound System (2015), cited by 4
- K153626: SonoSite Edge II Ultrasound System (2016), cited by 3
- K200964: Sonosite PX Ultrasound System (2020), cited by 2

## Recent decisions
- K260595: Sonosite iLOOK Ultrasound System (Mar 10, 2026)
- K253448: Sonosite MT Ultrasound System (Nov 3, 2025)
- K251106: Sonosite LX and Sonosite PX Ultrasound Systems (Aug 29, 2025)
- K251830: Sonosite LX Ultrasound System (Jul 10, 2025)
- K233597: Sonosite LX Ultrasound System (Dec 6, 2023)
- K213763: Sonosite PX Ultrasound System (Dec 27, 2021)
- K202160: Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System (Sep 1, 2020)
- K200964: Sonosite PX Ultrasound System (May 8, 2020)

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