LOGIQ Totus
K-Number: K253370 · 2026-01-08
Decision Date2026-01-08
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
LOGIQ Totus is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2026-01-08 under approval number K253370. 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 Totus?
LOGIQ Totus is a medical device that received FDA 510(k) clearance on 2026-01-08. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K253370.
When was LOGIQ Totus approved by the FDA?
LOGIQ Totus received FDA 510(k) clearance on 2026-01-08, under approval number K253370.
What company makes LOGIQ Totus?
LOGIQ Totus is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.
What is the FDA product code for LOGIQ Totus?
The FDA product code for LOGIQ Totus 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.