Acclarix LX8 Diagnostic Ultrasound System
K-Number: K162055 · 2017-01-31
ApplicantEdan Instruments, Inc.
Decision Date2017-01-31
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Acclarix LX8 Diagnostic Ultrasound System is a medical device manufactured by Edan Instruments, Inc.. It received FDA 510(k) clearance on 2017-01-31 under approval number K162055. 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 Acclarix LX8 Diagnostic Ultrasound System?
Acclarix LX8 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-01-31. It is manufactured by Edan Instruments, Inc.. The 510(k) number is K162055.
When was Acclarix LX8 Diagnostic Ultrasound System approved by the FDA?
Acclarix LX8 Diagnostic Ultrasound System received FDA 510(k) clearance on 2017-01-31, under approval number K162055.
What company makes Acclarix LX8 Diagnostic Ultrasound System?
Acclarix LX8 Diagnostic Ultrasound System is manufactured by Edan Instruments, Inc..
What is the FDA product code for Acclarix LX8 Diagnostic Ultrasound System?
The FDA product code for Acclarix LX8 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.