# K163702: Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: May 30, 2017 after 152 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: 20 generations back to K935595 (1995). 233 ancestors in all.
22 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)
- K161843: Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0, Toshibamedical Systems Corporation (2016) Summary page 4.
- K151451: Aplio 500/400/300 Diagnostic Ultrasound System V6.0, Toshibamedical Systems Corporation (2015) Summary page 37.

## Most influential descendants
- 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
- K212333: Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 (2022), 6 descendants of its own

## Recalls of this device
- Jan 4, 2018 · Class II · Z-2315-2018: The power supply unit may be damaged and may fail to start up when the power plug is inserted into a power outlet while the main power switch on the rear of the system is set to ON.

## 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/K163702
Methodology: https://510kreport.com/methodology