# K071134: Sonosite Maxx Series Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Sonosite,Inc.
- Decided: May 8, 2007 after 15 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K945773 (1995). 16 ancestors in all.
259 later devices descend from it; 6 cite it directly.
0 of 276 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043559: Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series), Sonosite,Inc. (2005) Summary page 12.
- K053069: Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series), Sonosite,Inc. (2005) Summary page 1.
- K034003: Hdi 5000 Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2004) 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.

## Most influential descendants
- K082098: Sonosite Maxx Series Ultrasound System (2008), 247 descendants of its own
- K113156: Sonosite Edge Ultrasound System (2011), 216 descendants of its own
- K133533: Logiq E (2014), 149 descendants of its own
- K143452: Logiq P9, Logiq P7 (2015), 131 descendants of its own
- K161047: LOGIQ P9 and LOGIQ P7 (2016), 107 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
- Aug 8, 2008 · Not classified · Z-2191-2010: The TEE transesophageal transducer, when connected to a SonoSite M-Turbo Ultrasound System, may exhibit erratic operation of the Scanplane Orientation Indicator on the system display. The indicator ma

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

Source page: https://510kreport.com/device/K071134
Methodology: https://510kreport.com/methodology