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

Canon Medical Systems Corporation · K252074 · 2025-10-31

Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System is an AI-enabled medical device from Canon Medical Systems Corporation, listed by FDA (510(k), K252074) with a decision date of 2025-10-31. Review panel: Radiology.

FDA submission numberK252074
Pathway510(k)
CompanyCanon Medical Systems Corporation
Review panel (specialty)Radiology
FDA decision date2025-10-31
DecisionSubstantially Equivalent
Product codeIYN
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Device class2
Regulation number892.1550
Review time (calendar days)121
Applicant countryJP

Official FDA database record · FDA AI-enabled device list

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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.