Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5

Canon Medical Systems Corporation · K212960 · 2022-03-22

Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 is an AI-enabled medical device from Canon Medical Systems Corporation, listed by FDA (510(k), K212960) with a decision date of 2022-03-22. Review panel: Radiology.

FDA submission numberK212960
Pathway510(k)
CompanyCanon Medical Systems Corporation
Review panel (specialty)Radiology
FDA decision date2022-03-22
DecisionSubstantially Equivalent
Product codeIYN
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Device class2
Regulation number892.1550
Review time (calendar days)187
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.