# K151451: Aplio 500/400/300 Diagnostic Ultrasound System V6.0

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Jul 9, 2015 after 41 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K935595 (1995). 231 ancestors in all.
34 later devices descend from it; 3 cite it directly.
6 of 266 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141459: Aplio 500/400/300 Diagnostic Ultrasound System, V5.0, Toshibamedical Systems Corporation (2014) Summary page 4.
- K072000: Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0, Toshiba America Medical Systems, In.C (2007) Summary page 47.
- K131937: Voluson I/E, GE Healthcare (2013) Summary page 47.
- K142160: Logiq E9 Diagnostic Ultrasound System, GE Healthcare (2014) Summary page 47.

## Most influential descendants
- 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
- K182679: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1 (2018), 10 descendants of its own
- K191467: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 (2019), 9 descendants of its own

## Recalls of this device
- May 1, 2017 · Class II · Z-2711-2017: When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workst
- May 1, 2017 · Class II · Z-2710-2017: When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workst

## 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/K151451
Methodology: https://510kreport.com/methodology