# K202737: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Xario200G and Xario100G, Diagnostic Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Canon Medical Systems Corporation
- Decided: Oct 16, 2020 after 28 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: 25 generations back to K935595 (1995). 398 ancestors in all.
No later device cites it as a predicate yet.
7 of 399 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191467: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0, Canon Medical Systems Corporation (2019) Summary page 7.
- K191663: Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0, Canon Medical Systems Corporation (2019) Summary page 7.
- K182596: Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System, Canon Medical Systems Corporation (2018) Summary page 7.

## Indications for use
The Diagnostic Ultrasound Systems Aplio 1900 Model TUS-A1900, Aplio i800 Model TUS-AI800, Aplio 1700 Model TUS-AI700 and Aplio 1600 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. The Diagnostic Ultrasound Systems Aplio a550 Model CUS-AAS550, Aplio a450 Model CUS-AA450, and Aplio a Model CUS-AA000 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. The Diagnostic Ultrasound System Xario200G Model CUS-X200G and Xario1 00G Model CUS-X100G 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), laparoscopic, pediatric, small organs, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal(superficial), cardiac adult, cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.

Source page: https://510kreport.com/device/K202737
Methodology: https://510kreport.com/methodology