Consulting Wallah › Device Explorer › Other devices › Cone beam computed tomography system, head/neck
Device Explorer · FDA GUDID · GMDN 61019

Cone beam computed tomography system, head/neck

A stationary assembly of mains electricity (AC-powered) devices intended to produce two- or three-dimensional (3-D) diagnostic digital x-ray images of the head/neck using cone beam computed tomography (CBCT). It consists of an x-ray source assembly, high-volta

US‑registered devices99in commercial distribution
Companies12labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription86%Rx‑only share
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Share of device records

Alliage S/A Indústrias Médico Odontológica3434%
Carestream Dental Llc1515%
Carestream Health, Inc.1313%
Xoran Technologies Llc88%
Dürr Dental Se66%
Dental Imaging Technologies Corporation66%
Fussen Technology Co., Ltd.55%
Prexion Corporation55%

Top labelers

CompanyDevicesShare
Alliage S/A Indústrias Médico Odontológica3434%
Carestream Dental Llc1515%
Carestream Health, Inc.1313%
Xoran Technologies Llc88%
Dürr Dental Se66%
Dental Imaging Technologies Corporation66%
Fussen Technology Co., Ltd.55%
Prexion Corporation55%
J.Morita Mfg.Corp.44%
Epica Human Health Llc11%
Icrco, Inc.11%
Cefla Societa' Cooperativa11%

Company = labeler of record on GUDID. 12 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

FUSSENPreXion3D ExpeditionPreXion3D Explorer PROPreXion3D Explorer EXPreXion3D ExplorerVeraview FX8003D Accuitomo XYZ Slice View TomographProVecta 3D Prime CephProVecta 3D PrimexCAT IQMiniCAT2020xCAT XLxCATMiniCATIQMiniCATSee Factor CT3

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
OASX-Ray, Tomography, Computed, Dental80
OASX-ray, tomography, computed, dental25
MUHSystem,x-ray,extraoral source,digital11
JAKSystem, X-Ray, Tomography, Computed11
MUHSystem,X-Ray,Extraoral Source,Digital11
MUHSystem, X-Ray, Extraoral Source, Digital5

GMDN & GCC registration

  • GMDN code 61019 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 86% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many cone beam computed tomography system, head/neck products are registered in the US?

99 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cone beam computed tomography system, head/neck", from 12 companies. The largest labeler is Alliage S/A Indústrias Médico Odontológica with 34% of records.

Which FDA product codes apply?

OAS (X-Ray, Tomography, Computed, Dental), OAS (X-ray, tomography, computed, dental), MUH (System,x-ray,extraoral source,digital), JAK (System, X-Ray, Tomography, Computed)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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