FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Healium Intelliscan Corporation. It received FDA 510(k) clearance on 2026-05-05 under 510(k) 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. The listed applicant is Healium Intelliscan Corporation. The 510(k) number is K261132.

When did Healium Intelliscan LX192LC receive FDA 510(k) clearance?

Healium Intelliscan LX192LC received FDA 510(k) clearance on 2026-05-05, under 510(k) number K261132.

Who is the listed applicant for Healium Intelliscan LX192LC?

The FDA 510(k) record lists Healium Intelliscan Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Healium Intelliscan LX192LC?

The FDA product code for Healium Intelliscan LX192LC is IYN.

Related Devices (Code: IYN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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