Customize— 510(k) K221432

Substantially Equivalent

3D-Side S.A.

FDA 510(k) clearance K221432 for Customize, Substantially Equivalent on 2022-08-03. Applicant: 3D-Side S.A.. Device class: 2.

Clearance details

Applicant: 3D-Side S.A.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2022-05-17
Decision date: 2022-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mont-Saint-Gulbert, BE

Download summary PDF View on FDA.gov ↗

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More clearances from 3D-Side S.A.

K213779 — Customize2022-03-16
K212237 — 3D-Cut2021-11-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.