# K182427: Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Canon Medical Systems Corporation
- Decided: Nov 2, 2018 after 57 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: 22 generations back to K935595 (1995). 262 ancestors in all.
4 later devices descend from it; 1 cites it directly.
6 of 267 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173090: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4, Toshibamedical Systems Corporation (2018) Summary page 5.

## Most influential descendants
- K191663: Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 (2019), 3 descendants of its own
- K202364: Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1 (2020), 1 descendant of its own
- K212960: Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 (2022), 0 descendants of its own
- 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 (2020), 0 descendants of its own

## Indications for use
The Diagnostic Ultrasound Systems Aplio a550 Model CUS-AA550 and Aplio a450 Model CUS-AA450 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/K182427
Methodology: https://510kreport.com/methodology