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Device Explorer · FDA GUDID · GMDN 35159

Linear accelerator system

An assembly of devices designed to produce high-energy electrons to yield high-energy x-rays used for therapeutic applications, primarily to treat cancer. It provides a uniform radiation field of uniform intensity and predictable energy level, in a beam with w

US‑registered devices169in commercial distribution
Companies11labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription66%Rx‑only share
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Share of device records

Varian Medical Systems, Inc.5935%
Accuray Incorporated5633%
Elekta Limited2716%
Elekta Solutions Ab95%
Viewray Incorporated74%
S.I.T. Sordina Iort Technologies Spa53%
Reflexion Medical, Inc.21%
Our United Corporation11%

Top labelers

CompanyDevicesShare
Varian Medical Systems, Inc.5935%
Accuray Incorporated5633%
Elekta Limited2716%
Elekta Solutions Ab95%
Viewray Incorporated74%
S.I.T. Sordina Iort Technologies Spa53%
Reflexion Medical, Inc.21%
Our United Corporation11%
Intraop Medical Corporation11%
Akesis Inc.11%
Radiadyne, L.L.C.11%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

EMLA (Elekta EVO)TaiChiAElekta Medical Linear AcceleratorElekta UnityIntegrity™NAVitalBeamTrueBeamEdgeTrilogyNovalis TXClinac iXEDGE Radiosurgery SystemVitalBeam Radiotherapy SystemTrueBeam Radiotherapy SystemTrilogy TX Image-Guided Radiosurgery

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

FDA product codes

CodeNameDevices
IYEAccelerator, linear, medical97
IYEAccelerator, Linear, Medical69
MUJSystem,Planning,Radiation Therapy Treatment12
MUJSystem, Planning, Radiation Therapy Treatment6
LNHSystem, Nuclear Magnetic Resonance Imaging5
KNHLaparoscopic Contraceptive Tubal Occlusion Device1

GMDN & GCC registration

  • GMDN code 35159 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 66% · 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.

How many linear accelerator system products are registered in the US?

169 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Linear accelerator system", from 11 companies. The largest labeler is Varian Medical Systems, Inc. with 35% of records.

Which FDA product codes apply?

IYE (Accelerator, linear, medical), IYE (Accelerator, Linear, Medical), MUJ (System,Planning,Radiation Therapy Treatment), MUJ (System, Planning, Radiation Therapy Treatment)

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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