# K212333: Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5

- Pathway: 510(k) (Traditional)
- Applicant: Canon Medical Systems Corporation
- Decided: Jan 24, 2022 after 181 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: 26 generations back to K935595 (1995). 392 ancestors in all.
6 later devices descend from it; 1 cites it directly.
7 of 399 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201972: Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1, Canon Medical Systems Corporation (2020) Summary page 5.

## Most influential descendants
- K223017: Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (2023), 5 descendants of its own
- K233195: Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System (2024), 3 descendants of its own
- 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

## 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 i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, and 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.

Source page: https://510kreport.com/device/K212333
Methodology: https://510kreport.com/methodology