Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1
K-Number: K202364 · 2020-10-15
ApplicantCanon Medical Systems Corporation
Decision Date2020-10-15
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1 is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2020-10-15 under approval number K202364. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1?
Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1 is a medical device that received FDA 510(k) clearance on 2020-10-15. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K202364.
When was Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1 approved by the FDA?
Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1 received FDA 510(k) clearance on 2020-10-15, under approval number K202364.
What company makes Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1?
Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1 is manufactured by Canon Medical Systems Corporation.
What is the FDA product code for Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1?
The FDA product code for Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1 is IYN.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.