# K191467: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0

- Pathway: 510(k) (Traditional)
- Applicant: Canon Medical Systems Corporation
- Decided: Jul 19, 2019 after 46 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: 24 generations back to K935595 (1995). 390 ancestors in all.
9 later devices descend from it; 2 cite it directly.
7 of 400 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182679: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1, Canon Medical Systems Corporation (2018) Summary page 4.
- K181098: ACUSON SC2000 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2018) Summary page 56.
- K180572: AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10, Supersonic Imagine (2018) Summary page 56.

## Most influential descendants
- 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
- K233195: Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System (2024), 3 descendants of its own
- K242808: Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 (2025), 2 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/K191467
Methodology: https://510kreport.com/methodology