Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)

Canon Medical Systems Corporation · K241582 · 2024-09-12

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700) is an AI-enabled medical device from Canon Medical Systems Corporation, listed by FDA (510(k), K241582) with a decision date of 2024-09-12. Review panel: Radiology.

FDA submission numberK241582
Pathway510(k)
CompanyCanon Medical Systems Corporation
Review panel (specialty)Radiology
FDA decision date2024-09-12
DecisionSubstantially Equivalent
Product codeIYN
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Device class2
Regulation number892.1550
Review time (calendar days)101
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.