LOGIQ Fortis
K-Number: K253366 · 2026-01-07
Decision Date2026-01-07
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
LOGIQ Fortis is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2026-01-07 under approval number K253366. 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 Fortis?
LOGIQ Fortis is a medical device that received FDA 510(k) clearance on 2026-01-07. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K253366.
When was LOGIQ Fortis approved by the FDA?
LOGIQ Fortis received FDA 510(k) clearance on 2026-01-07, under approval number K253366.
What company makes LOGIQ Fortis?
LOGIQ Fortis is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.
What is the FDA product code for LOGIQ Fortis?
The FDA product code for LOGIQ Fortis 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.