Cleared Traditional

Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System

K253597 · Canon Medical Systems Corporation · Radiology
Jan 2026
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K253597 is an FDA 510(k) clearance for the Aplio beyond and Aplio me Software V2.0 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 January 20, 2026, 63 days after receiving the submission on November 18, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K253597 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 2025
Decision Date January 20, 2026
Days to Decision 63 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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