Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0
K-Number: K161843 · 2016-09-21
ApplicantToshibamedical Systems Corporation
Decision Date2016-09-21
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 is a medical device manufactured by Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2016-09-21 under approval number K161843. 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/i800/i700 Diagnostic Ultrasound System, V2.0?
Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 is a medical device that received FDA 510(k) clearance on 2016-09-21. It is manufactured by Toshibamedical Systems Corporation. The 510(k) number is K161843.
When was Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 approved by the FDA?
Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 received FDA 510(k) clearance on 2016-09-21, under approval number K161843.
What company makes Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0?
Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 is manufactured by Toshibamedical Systems Corporation.
What is the FDA product code for Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0?
The FDA product code for Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 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.