Xario 100 Diagnostic Ultrasound System, V5.0
K-Number: K162187 · 2016-09-30
ApplicantToshibamedical Systems Corporation
Decision Date2016-09-30
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Xario 100 Diagnostic Ultrasound System, V5.0 is a medical device manufactured by Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2016-09-30 under approval number K162187. 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 Xario 100 Diagnostic Ultrasound System, V5.0?
Xario 100 Diagnostic Ultrasound System, V5.0 is a medical device that received FDA 510(k) clearance on 2016-09-30. It is manufactured by Toshibamedical Systems Corporation. The 510(k) number is K162187.
When was Xario 100 Diagnostic Ultrasound System, V5.0 approved by the FDA?
Xario 100 Diagnostic Ultrasound System, V5.0 received FDA 510(k) clearance on 2016-09-30, under approval number K162187.
What company makes Xario 100 Diagnostic Ultrasound System, V5.0?
Xario 100 Diagnostic Ultrasound System, V5.0 is manufactured by Toshibamedical Systems Corporation.
What is the FDA product code for Xario 100 Diagnostic Ultrasound System, V5.0?
The FDA product code for Xario 100 Diagnostic Ultrasound System, V5.0 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.