# K133761: Aplio 500/400/300 Diagnostic Ultrasound System V4.0

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Apr 22, 2014 after 132 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: 16 generations back to K935595 (1995). 132 ancestors in all.
72 later devices descend from it; 3 cite it directly.
0 of 205 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123992: Aplio 500/400/300 V3.0, Toshibamedical Systems Corporation (2013) Summary page 1.

## Most influential descendants
- K142517: SoftVue (2014), 49 descendants of its own
- K150949: FibroScan (2015), 42 descendants of its own
- K160524: FibroScan 530 Compact (2016), 41 descendants of its own
- K141459: Aplio 500/400/300 Diagnostic Ultrasound System, V5.0 (2014), 39 descendants of its own
- K151451: Aplio 500/400/300 Diagnostic Ultrasound System V6.0 (2015), 34 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, and musculo-skeletal (both conventional and superficial).

Source page: https://510kreport.com/device/K133761
Methodology: https://510kreport.com/methodology