FDA 510(k)

Healium 智能掃描 LX192LC

K 號：K261132 · 2026-05-05

決定日期2026-05-05

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

相關器械（代碼：IYN）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：IYN）

官方來源