# K253597: Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Canon Medical Systems Corporation
- Decided: Jan 20, 2026 after 63 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: 30 generations back to K935595 (1995). 396 ancestors in all.
No later device cites it as a predicate yet.
7 of 397 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242808: Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5, Canon Medical Systems Corporation (2025) Summary page 6.

## Indications for use
The Diagnostic Ultrasound System Aplio beyond Model CUS-ABE00, Aplio me Model CUS-AME00 are indicated for the visualization of structures, and dynamic processes within 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 (thyroid, breast and 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: B mode, M mode, Continuous Wave, Color Doppler, Pulsed Wave Doppler, Power Doppler and Combination Doppler, as well as Speckle-tracking, Tissue Harmonic Imaging, Combined Modes, Shear wave, Elastography, and Acoustic attenuation mapping. This system is suitable for use in hospital and clinical settings by physicians or appropriately trained healthcare professionals.

Source page: https://510kreport.com/device/K253597
Methodology: https://510kreport.com/methodology