Healium Intelliscan LX192LC
K-Number: K261132 · 2026-05-05
ApplicantHealium Intelliscan Corporation
Decision Date2026-05-05
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Healium Intelliscan LX192LC is a medical device manufactured by Healium Intelliscan Corporation. It received FDA 510(k) clearance on 2026-05-05 under approval number K261132. 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 Healium Intelliscan LX192LC?
Healium Intelliscan LX192LC is a medical device that received FDA 510(k) clearance on 2026-05-05. It is manufactured by Healium Intelliscan Corporation. The 510(k) number is K261132.
When was Healium Intelliscan LX192LC approved by the FDA?
Healium Intelliscan LX192LC received FDA 510(k) clearance on 2026-05-05, under approval number K261132.
What company makes Healium Intelliscan LX192LC?
Healium Intelliscan LX192LC is manufactured by Healium Intelliscan Corporation.
What is the FDA product code for Healium Intelliscan LX192LC?
The FDA product code for Healium Intelliscan LX192LC 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.