# K132274: Aixplorer

- Pathway: 510(k) (Special)
- Applicant: Supersonic Imagine
- Decided: Sep 24, 2013 after 64 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: 14 generations back to K935595 (1995). 74 ancestors in all.
312 later devices descend from it; 6 cite it directly.
0 of 387 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112255: Aixplorer, Supersonic Imagine (2012) Summary page 1.
- K121329: Aixplorer, Supersonic Imagine (2012) Summary page 1.

## Most influential descendants
- K142160: Logiq E9 Diagnostic Ultrasound System (2014), 263 descendants of its own
- K152309: LOGIQ E9, LOGIQ E9 XDClear 2.0 (2015), 100 descendants of its own
- K151663: RS80A Diagnostic Ultrasound System (2015), 96 descendants of its own
- K152962: HS70A Diagnostic Ultrasound System (2015), 90 descendants of its own
- K153529: WS80A Diagnostic Ultrasound System (2016), 89 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, Trans-vaginal and Neonatal Cephalic. The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal Cephalic).

Source page: https://510kreport.com/device/K132274
Methodology: https://510kreport.com/methodology