# K091970: Aixplorer Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Supersonic Imagine
- Decided: Aug 12, 2009 after 42 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: 11 generations back to K935595 (1995). 63 ancestors in all.
528 later devices descend from it; 2 cite it directly.
2 of 592 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072786: Acuson S2000 Ultrasound System, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.
- K030455: Boris Platform Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2003) Summary page 1.

## Most influential descendants
- K102041: Aixplorer (2010), 527 descendants of its own
- K112255: Aixplorer (2012), 525 descendants of its own
- K121329: Aixplorer (2012), 405 descendants of its own
- K132274: Aixplorer (2013), 312 descendants of its own
- K142160: Logiq E9 Diagnostic Ultrasound System (2014), 263 descendants of its own

## Indications for use
The SuperSonic Imagine AIXPLORER® ultrasound system is indicated for use in the following applications: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskelelal and Peripheral Vascular. The system also provides the abilily to measure anatomical structures (abdominal, small organs, rnusculoskeletal, superficial musculoskeletal and peripheral vascular).

Source page: https://510kreport.com/device/K091970
Methodology: https://510kreport.com/methodology