# K212960: Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5

- Pathway: 510(k) (Traditional)
- Applicant: Canon Medical Systems Corporation
- Decided: Mar 22, 2022 after 187 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 25 generations back to K935595 (1995). 265 ancestors in all.
No later device cites it as a predicate yet.
6 of 266 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202364: Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1, Canon Medical Systems Corporation (2020) Summary page 5.

## Recalls of this device
- Sep 29, 2022 · Class II · Z-0198-2023: After completion, ultrasound system's Stress Echo may not terminate if user does not manually terminate the protocol. During next patient exam, an abnormal confirmation message will be displayed "Same

## Indications for use
The Diagnostic Ultrasound System Aplio a550 Model CUS-AA550,Aplio a450 Model CUSAA450 and Aplio a Model CUS-AA000 is 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/K212960
Methodology: https://510kreport.com/methodology