Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System
K-Number: K252074 · 2025-10-31
ApplicantCanon Medical Systems Corporation
Decision Date2025-10-31
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2025-10-31 under approval number K252074. 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 i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System?
Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2025-10-31. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K252074.
When was Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System approved by the FDA?
Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System received FDA 510(k) clearance on 2025-10-31, under approval number K252074.
What company makes Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System?
Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System is manufactured by Canon Medical Systems Corporation.
What is the FDA product code for Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System?
The FDA product code for Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System 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.