Cleared Traditional

Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System

K252074 · Canon Medical Systems Corporation · Radiology
Oct 2025
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K252074 is an FDA 510(k) clearance for the Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Canon Medical Systems Corporation (Otawara-Shi, JP). The FDA issued a Cleared decision on October 31, 2025, 121 days after receiving the submission on July 2, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K252074 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2025
Decision Date October 31, 2025
Days to Decision 121 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1550

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