# K202364: Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1

- Pathway: 510(k) (Traditional)
- Applicant: Canon Medical Systems Corporation
- Decided: Oct 15, 2020 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: 24 generations back to K935595 (1995). 264 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 266 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191663: Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0, Canon Medical Systems Corporation (2019) Summary page 5.

## Most influential descendants
- K212960: Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 (2022), 0 descendants of its own

## Indications for use
The Diagnostic Ultrasound System Aplio a550 Model CUS-AA550,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 (including thyroid, breast, testicle), trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial), laparoscopic and thoracic/pleural. This system provides high-quality ultrasound images in the following modes of operation: B (2D), M, Color Doppler (blood-flow imaging), Doppler (PWD, CWD, Power) (blood-flow spectrum), Combined (B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD), Precision Imaging, Apli Pure, Micro Pure, BEAM, TDI, Shear wave, Elastography, SMI (ADF), 2D Wall Motion Tracking, Smart 3D, Smart Sensor3D, 3D Color (Volume color), 4D, STIC, STIC Color, Fusion, Smart Navigation, ATI, CHI (Per FDA approved contrast agent prescribing information), Shadow Glass. This system is suitable for use in hospital and clinical settings by physicians or legally qualified persons who have received the appropriate training.

Source page: https://510kreport.com/device/K202364
Methodology: https://510kreport.com/methodology