# K173090: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Jan 11, 2018 after 104 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: 21 generations back to K935595 (1995). 261 ancestors in all.
21 later devices descend from it; 3 cite it directly.
6 of 283 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163702: Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1, Toshibamedical Systems Corporation (2017) Summary page 4.
- K030455: Boris Platform Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2003) Summary page 49.
- K131514: GE Vivid E9 Diagnostic Ultrasound Imaging System, Ge Vingmed Ultrasound AS (2013) Summary page 49.
- K120221: GE Echopac, GE Healthcare (2012) Summary page 49.
- K140729: Aplio Artida, V3.2, Toshiba America Medical Systems, In.C (2014) Summary page 49.
- K162269: Voluson E6, Voluson E8, Voluson E10, GE Healthcare (2016) Summary page 49.
- K062247: HD11 Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2006) Summary page 49.

## Most influential descendants
- 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
- K223017: Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (2023), 5 descendants of its own

## Indications for use
The Diagnostic Ultrasound Systems Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600 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/K173090
Methodology: https://510kreport.com/methodology