# K161999: Aixplorer

- Pathway: 510(k) (Traditional)
- Applicant: Supersonic Imagine
- Decided: Nov 16, 2016 after 119 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: 17 generations back to K935595 (1995). 218 ancestors in all.
20 later devices descend from it; 1 cites it directly.
1 of 239 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142100: Aixplorer, Supersonic Imagine (2014) Summary page 4.
- K132274: Aixplorer, Supersonic Imagine (2013) Summary page 18.
- K133905: 6200 / 6250 Ultrasound System, Esaote, S.p.A. (2014) Summary page 18.
- K133761: Aplio 500/400/300 Diagnostic Ultrasound System V4.0, Toshibamedical Systems Corporation (2014) Summary page 18.

## Most influential descendants
- K171105: AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems (2017), 19 descendants of its own
- K173021: Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems (2018), 18 descendants of its own
- K180572: AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 (2018), 16 descendants of its own
- K191467: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 (2019), 9 descendants of its own
- K201972: Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1 (2020), 7 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, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal/Adult Cephalic, and Non-invasive Cardiac. The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, Intraoperative, GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal/Adult Cephalic, Fetal/Obstetrics, Cardiac).

Source page: https://510kreport.com/device/K161999
Methodology: https://510kreport.com/methodology