510(k) clearance

MD-6000S Bladder Scanner

FDA 510(k) source

510(k) number

K260313

Applicant

MEDA Co., Ltd.

Decision date

Sep 24, 2026

Date received

Jan 30, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

IYO

Device type

System, Imaging, Pulsed Echo, Ultrasonic

Device class

Class II

Regulation

21 CFR 892.1560

Advisory committee

Radiology

Statement or summary

Summary

Third party

N

Location

Tianjin, CN