# K043559: Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)

- Pathway: 510(k) (Traditional)
- Applicant: Sonosite,Inc.
- Decided: Jan 12, 2005 after 16 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K945773 (1995). 6 ancestors in all.
678 later devices descend from it; 5 cite it directly.
0 of 685 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030949: Titan High Resolution Ultrasound System, Sonosite,Inc. (2003) Summary page 1.
- K011224: Hdi 5000 Ultrasound System with Assisted Border Detection (Abd), Xres Imaging, and Panoramic Measurement Capability, Advanced Technology Laboratories, Inc. (2001) Summary page 1.
- K011188: GE Logiq 9, Model 2188900-X, GE Medical Systems (2001) Summary page 1.
- K020353: Omnia X/XS Ultrasound System, Siemens Medical Systems, Inc. (2002) Summary page 1.

## Most influential descendants
- K053069: Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) (2005), 676 descendants of its own
- K080935: Sonix MDP Ultrasound Scanner (2008), 584 descendants of its own
- K080223: Zura Tee System (2008), 583 descendants of its own
- K083095: Sonixtouch Ultrasound System (2008), 582 descendants of its own
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 (2009), 569 descendants of its own

## Recalls of this device
- Jul 18, 2011 · Not classified · Z-0057-2012: This is a software anomaly. In some circumstances, if the Systolic/Diastolic (S/D) ratio value is interpreted directly from the display, the clinician could potentially use an incorrect value of the S
- Nov 2, 2007 · Not classified · Z-2655-2010: Sterilization of the SonoSite SLT ultrasound surgical transducer with the Sterrad NX System may result in damage to the transducer.
- Nov 2, 2007 · Not classified · Z-2654-2010: Sterilization of the SonoSite LAP surgical Transducer with the Sterrad NX System may result in damage to the transducer.
- Feb 5, 2007 · Not classified · Z-0661-2007: Laparoscopic transducer exceeds the limits specified for radio-frequency emissions by up to 10db.

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K043559
Methodology: https://510kreport.com/methodology