# K233195: Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Canon Medical Systems Corporation
- Decided: Jan 24, 2024 after 118 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: 28 generations back to K935595 (1995). 394 ancestors in all.
3 later devices descend from it; 1 cites it directly.
7 of 398 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223017: Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0, Canon Medical Systems Corporation (2023) Summary page 5.

## Most influential descendants
- K242808: Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 (2025), 2 descendants of its own
- K253597: Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System (2026), 0 descendants of its own
- K252074: Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System (2025), 0 descendants of its own

## Indications for use
The Diagnostic Ultrasound System Aplio i900 Model TUS-AI900,Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 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(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 legally qualified persons who have received the appropriate training. In addition to the aforementioned indications for use, when EUS transducer GF-UCT180 is connected, Aplio i800 Model TUS-AI800 /E3 provides image information for diagnosis of the upper gastrointestinal tract and surrounding organs.

Source page: https://510kreport.com/device/K233195
Methodology: https://510kreport.com/methodology