Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5
K-Number: K212960 · 2022-03-22
ApplicantCanon Medical Systems Corporation
Decision Date2022-03-22
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2022-03-22 under approval number K212960. 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, and Aplio a, Diagnostic Ultrasound System, Software V6.5?
Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 is a medical device that received FDA 510(k) clearance on 2022-03-22. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K212960.
When was Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 approved by the FDA?
Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 received FDA 510(k) clearance on 2022-03-22, under approval number K212960.
What company makes Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5?
Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 is manufactured by Canon Medical Systems Corporation.
What is the FDA product code for Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5?
The FDA product code for Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 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.