510(k) clearance

GC85A

FDA 510(k) source

510(k) number

K260481

Applicant

Samsung Electronics Co., Ltd.

Decision date

Aug 27, 2026

Date received

Feb 13, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

KPR

Device type

System, X-Ray, Stationary

Device class

Class II

Regulation

21 CFR 892.1680

Advisory committee

Radiology

Statement or summary

Summary

Third party

N

Location

Suwon-Si, KR