# K141459: Aplio 500/400/300 Diagnostic Ultrasound System, V5.0

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Oct 28, 2014 after 148 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). 204 ancestors in all.
39 later devices descend from it; 2 cite it directly.
6 of 244 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133761: Aplio 500/400/300 Diagnostic Ultrasound System V4.0, Toshibamedical Systems Corporation (2014) Summary page 5.
- K112255: Aixplorer, Supersonic Imagine (2012) Summary page 45.
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4, GE Healthcare (2009) Summary page 45.
- K092619: Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal Tracker, Civco (2009) Summary page 45.
- K053069: Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series), Sonosite,Inc. (2005) Summary page 45.

## Most influential descendants
- K151451: Aplio 500/400/300 Diagnostic Ultrasound System V6.0 (2015), 34 descendants of its own
- K161843: Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 (2016), 23 descendants of its own
- K163702: Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 (2017), 22 descendants of its own
- K173090: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 (2018), 21 descendants of its own
- K171105: AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems (2017), 19 descendants of its own

## Indications for use
The Diagnostic Ultrasound System Aplio 500 Model TUS-A500, Aplio 400 Model TUS-A400 And Aplio 300 Model TUS-A300 is indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial) and laparoscopic.

Source page: https://510kreport.com/device/K141459
Methodology: https://510kreport.com/methodology