FDA 510(k) clearance · back to tracker

ASUS Ultrasound Imaging System (LU800 series)

Asustek Computer, Inc. cleared K250791 on 2025-12-04, decision: substantially equivalent

K-number

K250791

Sponsor

Asustek Computer, Inc.

Device

ASUS Ultrasound Imaging System (LU800 series)

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-12-04

Product code

IYN

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1550

Official FDA record

Open K250791on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.