# K112255: Aixplorer

- Pathway: 510(k) (Traditional)
- Applicant: Supersonic Imagine
- Decided: Aug 28, 2012 after 389 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: 13 generations back to K935595 (1995). 72 ancestors in all.
525 later devices descend from it; 9 cite it directly.
2 of 598 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091970: Aixplorer Ultrasound System, Supersonic Imagine (2009) Summary page 1.
- K102041: Aixplorer, Supersonic Imagine (2010) Summary page 1.

## Most influential descendants
- K132274: Aixplorer (2013), 312 descendants of its own
- K142160: Logiq E9 Diagnostic Ultrasound System (2014), 263 descendants of its own
- K130499: IU22 Diagnostic Ultrasound System (2013), 212 descendants of its own
- K132304: Epiq Diagnostic Ultrasound System (2013), 211 descendants of its own
- K130739: Acuson S2000 and S3000 Diagnostic Ultrasound Systems (2013), 177 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 Musculoskeletal, Vascular, Peripheral Vascular, GYN, Pelvic, Pediatric, Urology, Trans-rectal and Trans-vaginal. The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, GYN, Pelvic, Pediatric, Urology, Trans- rectal and Trans-vaginal).

Source page: https://510kreport.com/device/K112255
Methodology: https://510kreport.com/methodology