510(k) clearance

HipStudio Analysis

FDA 510(k) source

510(k) number

K262442

Applicant

Replasia BV

Decision date

Sep 22, 2026

Date received

Jul 16, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

LLZ

Device type

System, Image Processing, Radiological

Device class

Class II

Regulation

21 CFR 892.2050

Advisory committee

Radiology

Statement or summary

Summary

Third party

N

Location

Leuven, BE