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Device Explorer · FDA GUDID · GMDN 35618

X-ray tube housing assembly, diagnostic

A metallic (e.g., steel, aluminium alloy) case that houses an x-ray tube to provide appropriate limits for x-ray leakage and adequate insulation to avoid electric risks during a diagnostic x-ray procedure. It includes sheet lead surrounds at appropriate locati

US‑registered devices365in commercial distribution
Companies11labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription5%Rx‑only share
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Share of device records

Philips Medical Systems Dmc Gmbh16746%
Canon Electron Tubes & Devices Co. Ltd.7621%
Shimadzu Corporation5615%
Mingwei Medical Technology(Suzhou)Co.,Ltd226%
I.A.E. Industria Applicazioni Elettroniche Spa175%
Chronos Imaging Llc103%
Hangzhou Kailong Medical Instruments Co.,Ltd.62%
Source-Ray, Inc.51%

Top labelers

CompanyDevicesShare
Philips Medical Systems Dmc Gmbh16746%
Canon Electron Tubes & Devices Co. Ltd.7621%
Shimadzu Corporation5615%
Mingwei Medical Technology(Suzhou)Co.,Ltd226%
I.A.E. Industria Applicazioni Elettroniche Spa175%
Chronos Imaging Llc103%
Hangzhou Kailong Medical Instruments Co.,Ltd.62%
Source-Ray, Inc.51%
Spellman High Voltage Electronics(Suzhou Industrial Park) Co., Ltd21%
Midmark Corporation21%
Richardson Electronics, Ltd.21%

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

Brand names on the register (sample)

S Spellman High Voltage Electronics CorporationRADIIRotating Anode X-ray Tube Assembly0.7/1.3U163C-360.6/1.2P18DE-850.6/1.2P366D-1500.6/1.2P326D-1501/2P18DK-851/2P13DK-850.6/1.2P364DK-1250.6/1.2P324DK-1250.6/1.2P364DK-850.6/1.2P38DE-850.6/1.2P33DK-850.6/1.2P13DK-850.6/1.2P324DK-85

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

FDA product codes

CodeNameDevices
ITYAssembly, tube housing, x-ray, diagnostic234
ITYAssembly, Tube Housing, X-Ray, Diagnostic217
MUHSystem,X-Ray,Extraoral Source,Digital1
EHDUnit, X-Ray, Extraoral With Timer1

GMDN & GCC registration

  • GMDN code 35618 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 5% · 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 x-ray tube housing assembly, diagnostic products are registered in the US?

365 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "X-ray tube housing assembly, diagnostic", from 11 companies. The largest labeler is Philips Medical Systems Dmc Gmbh with 46% of records.

Which FDA product codes apply?

ITY (Assembly, tube housing, x-ray, diagnostic), ITY (Assembly, Tube Housing, X-Ray, Diagnostic), MUH (System,X-Ray,Extraoral Source,Digital), EHD (Unit, X-Ray, Extraoral With Timer)

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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