# K161843: Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Sep 21, 2016 after 78 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K935595 (1995). 232 ancestors in all.
23 later devices descend from it; 1 cites it directly.
6 of 256 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151451: Aplio 500/400/300 Diagnostic Ultrasound System V6.0, Toshibamedical Systems Corporation (2015) Summary page 7.

## Most influential descendants
- 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
- K201972: Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1 (2020), 7 descendants of its own

## Recalls of this device
- May 1, 2017 · Class II · Z-2712-2017: 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 Systems Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800 and Aplio i700 Model TUS-AI700 are 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/K161843
Methodology: https://510kreport.com/methodology