LOGIQ E10
K-Number: K251985 · 2025-10-29
Decision Date2025-10-29
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
LOGIQ E10 is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2025-10-29 under approval number K251985. 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 E10?
LOGIQ E10 is a medical device that received FDA 510(k) clearance on 2025-10-29. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K251985.
When was LOGIQ E10 approved by the FDA?
LOGIQ E10 received FDA 510(k) clearance on 2025-10-29, under approval number K251985.
What company makes LOGIQ E10?
LOGIQ E10 is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.
What is the FDA product code for LOGIQ E10?
The FDA product code for LOGIQ E10 is IYN.
Other Devices by GE Medical Systems Ultrasound and Primary Care Diagnostics
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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.