510(k) clearance

Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630)

FDA 510(k) source

510(k) number

K262412

Applicant

Barco NV

Decision date

Oct 2, 2026

Date received

Jul 15, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

PGY

Device type

Display, Diagnostic Radiology

Device class

Class II

Regulation

21 CFR 892.2050

Advisory committee

Radiology

Statement or summary

Summary

Third party

N

Location

Kortrijk, BE