510(k) clearance

REMEX-T(K)100C

FDA 510(k) source

510(k) number

K261943

Applicant

Remedi, Inc.

Decision date

Oct 2, 2026

Date received

Jun 10, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

IZL

Device type

System, X-Ray, Mobile

Device class

Class II

Regulation

21 CFR 892.1720

Advisory committee

Radiology

Statement or summary

Summary

Third party

N

Location

Seoul, KR