LOGIQ E9, LOGIQ E9 XDClear 2.0
K-Number: K163077 · 2016-11-17
Decision Date2016-11-17
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
LOGIQ E9, LOGIQ E9 XDClear 2.0 is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2016-11-17 under approval number K163077. 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 LOGIQ E9, LOGIQ E9 XDClear 2.0?
LOGIQ E9, LOGIQ E9 XDClear 2.0 is a medical device that received FDA 510(k) clearance on 2016-11-17. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K163077.
When was LOGIQ E9, LOGIQ E9 XDClear 2.0 approved by the FDA?
LOGIQ E9, LOGIQ E9 XDClear 2.0 received FDA 510(k) clearance on 2016-11-17, under approval number K163077.
What company makes LOGIQ E9, LOGIQ E9 XDClear 2.0?
LOGIQ E9, LOGIQ E9 XDClear 2.0 is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.
What is the FDA product code for LOGIQ E9, LOGIQ E9 XDClear 2.0?
The FDA product code for LOGIQ E9, LOGIQ E9 XDClear 2.0 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.