# K102390: Sonosite Nanomaxx Series Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Sonosite,Inc.
- Decided: Nov 19, 2010 after 88 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K945773 (1995). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092058: Sonosite Nanomaxx Series Ultrasound System, Sonosite,Inc. (2009) Summary page 1.
- 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.

## 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/OB3; Abdominal; Pediatric; Small Organ (breast, thyroid, testicles, prostate); Trans-rectal; Trans-vaginal Peripheral Vessel; Intra-operative (abdominal organs, vascular); Musculoskeletal Conventional & Superficial, Cardiac Adult and Pediatric.

Source page: https://510kreport.com/device/K102390
Methodology: https://510kreport.com/methodology