Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System— 510(k) K233195

Clearance details

Applicant

Canon Medical Systems Corporation

Product code

Code IYN

Device class

Class 2

Regulation

21 CFR 892.1550

Advisory panel

Radiology

Date received

2023-09-28

Decision date

2024-01-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Otawara-Shi, JP

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• K253625 — Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR2026-03-27
• K260078 — Aquilion ServeSP (TSX-307B) V2.02026-03-13
• K253584 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)2026-03-10
• K253597 — Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System2026-01-20

Death

25

Injury

163

Malfunction

1,538

Other

4

Total

1,730

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →