Skip to content

Customize

by 3D-Side S.A. Belgium 510(k)

510(k) K221432

Product code QIH

Overview

Customize is a web-based 3D medical software platform designed for pre-surgical planning and patient-specific case management. The system facilitates the creation and supervision of the production of patient-specific anatomical models, instruments, and implants.

This device is supplied as a software platform to connect surgeons, patients, engineers, and designers. It has received FDA 510K clearance.

Summary written by AI from registry data, 25 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK221432 Date3 Aug 2022ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
QIH
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from 3D-Side S.A.

  • Customize

    Class II

  • 3D-Cut

    Class II

Questions

  • What is the primary purpose of the Customize software platform?

    Customize is a web-based 3D medical software platform designed to facilitate pre-surgical planning and patient-specific case management. It serves as a collaborative system that connects surgeons, patients, engineers, and designers to supervise the creation of anatomical models, surgical instruments, and implants.

  • How is the Customize platform supplied to users?

    The device is supplied as a web-based software platform. This digital delivery method allows for the coordination and supervision of patient-specific medical device production between clinical and technical teams.

  • What is the regulatory status of the Customize software?

    The Customize platform has received FDA 510K clearance. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices under the product code QIH.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K221432 24 fields · synced 22 Oct 2026