510(k) clearance

QGuideCT (1.0)

FDA 510(k) source

510(k) number

K260523

Applicant

Medis Medical Imaging Systems BV

Decision date

Oct 5, 2026

Date received

Feb 17, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

QIH

Device type

Automated Radiological Image Processing Software

Device class

Class II

Regulation

21 CFR 892.2050

Advisory committee

Radiology

Statement or summary

Statement

Third party

N

Location

Leiden, NL