# K232988: Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Canon Medical Systems Corporation
- Decided: Nov 21, 2023 after 60 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: 21 generations back to K935595 (1995). 137 ancestors in all.
No later device cites it as a predicate yet.
0 of 138 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182596: Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System, Canon Medical Systems Corporation (2018) Summary page 5.

## Indications for use
The Diagnostic Ultrasound System Aplio flex Model CUS-AFL00 and Aplio go Model CUS-AGG00 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, pediatric, small organ (thyroid, breast and testicle), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculoskeletal (both conventional and superficial), cardiac, peripheral vascular, and thoracic/pleural. This system provides high-quality ultrasound images in the following modes: B mode, M mode, Continuous Wave, Color Doppler, Pulsed Wave Doppler , Power Doppler as well as Tissue Harmonic Imaging, Combined Modes and Acoustic attenuation mapping. 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/K232988
Methodology: https://510kreport.com/methodology