# K092058: Sonosite Nanomaxx Series Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Sonosite,Inc.
- Decided: Oct 2, 2009 after 86 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- 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: 7 generations back to K945773 (1995). 22 ancestors in all.
27 later devices descend from it; 2 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071134: Sonosite Maxx Series Diagnostic Ultrasound System, Sonosite,Inc. (2007) Summary page 1.
- K082098: Sonosite Maxx Series Ultrasound System, Sonosite,Inc. (2008) 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
- K101605: Mylabone Ultrasound System (2010), 25 descendants of its own
- K111302: Mylabseven, Mylabalpha (2011), 24 descendants of its own
- K132466: Mylabseven 6400, Mylabalpha 7400 (2013), 22 descendants of its own
- K132231: Mylabseven, Mylabalpha (2013), 22 descendants of its own
- K142008: Mylabseven, Mylabalpha (2014), 19 descendants of its own

## Recalls of this device
- Aug 13, 2010 · Not classified · Z-0478-2011: Software ARM version 60.80.101.025 (referred to as Nano1.0.5) on the NanoMaxx ultrasound system results in errors when the "print" command is selected. As a result, the displayed MI or TI values may b
- May 27, 2010 · Not classified · Z-2116-2010: PowerPark system has a potential for loss of power at the corresponding wall outlet and/or circuit due to poor alignment.

## Indications for use
The SonoSite NanoMaxx Series Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal; Pediatric; Small Organ (breast, thyroid, testicles, prostate); Peripheral Vessel; Intra-operative (abdominal organs, vascular); Musculoskeletal Conventional & Superficial, Cardiac Adult and Pediatric.

Source page: https://510kreport.com/device/K092058
Methodology: https://510kreport.com/methodology