← Back to catalogue

Dental Computed Tomography X-Ray System Green X

FDA 510(k)

Class II (US FDA 510(k))

510(k) K201627

by Vatech Co., Ltd.

Identifiers

510(k) Number
K201627 FDA 510(k)
FDA Product Code
OAS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1750 FDA 510(k)
Regulation Number
892.1750 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Dental Computed Tomography X-Ray System Green X is a multi-modal dental imaging device designed for panoramic (pano), cephalometric (ceph, optional), cone-beam computed tomography (CBCT), and dental model scanning. It generates high-resolution 3D and 2D images of dental and maxillofacial structures, enabling precise diagnostic assessments for planning orthodontic, surgical, and restorative treatments.

This system is supplied as a reusable medical device intended for use in dental clinics, oral surgery centers, and radiology departments. It operates under FDA 510(k) clearance (K201627) and adheres to Class II regulatory standards (regulation number 892.1750). The device requires proper calibration, maintenance, and adherence to radiation safety protocols. No sterility or single-use specifications are indicated in the regulatory data.

This description and any FAQs above were generated automatically from registry data 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. Sources consulted: Green X - Vatech America, Green X - 3D Imaging Systems - VATECH, Green X™ 12 - Vatech Europe, Green X™ 16 - Vatech Europe

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Vatech Co., Ltd.

Sources (1)

  • FDA 510(k) K201627 24 fields · synced Sep 19, 2026