510(k) clearance

VenusCT

FDA 510(k) source

510(k) number

K260510

Applicant

Linatech, LLC

Decision date

Oct 19, 2026

Date received

Feb 17, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

SFV

Device type

X-Ray, Computed Tomography, Cone-Beam

Device class

Class II

Regulation

21 CFR 892.1750

Advisory committee

Radiology

Statement or summary

Summary

Third party

N

Location

Sunnyvale, CA, US