# K101757: Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Sonosite,Inc.
- Decided: Aug 12, 2010 after 50 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K961459 (1997). 4 ancestors in all.
339 later devices descend from it; 5 cite it directly.
0 of 344 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014116: Hand-Carried Ultrasound System, Sonosite,Inc. (2001) Summary page 2.

## Most influential descendants
- K113647: DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound System (2011), 116 descendants of its own
- K121010: M7/M7T Diagnostic Ultrasound System (2012), 107 descendants of its own
- K120699: DC-T6 Diagnostic Ultrasound System (2012), 103 descendants of its own
- K132228: Ugeo PT60A Diagnostic Ultrasound System (2013), 101 descendants of its own
- K142466: UGEO PT60A Diagnostic Ultrasound System (2014), 99 descendants of its own

## Indications for use
The SonoSite Series Ultrasound Systems are 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: Ophthalmic, Fetal/OB; Abdominal; Intra-operative (abdominal organs and vascular); Laparoscopic; Pediatric; Small Organ (breast, thyroid, testicles, prostate); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Trans-esophageal (cardiac); Peripheral Vessel.

Source page: https://510kreport.com/device/K101757
Methodology: https://510kreport.com/methodology