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Device Explorer · FDA GUDID · GMDN 37643

Portable basic diagnostic x-ray system, digital

An assembly of devices that comprise a general-purpose portable diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The portable design allows it to ope

US‑registered devices83in commercial distribution
Companies14labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription49%Rx‑only share
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Share of device records

Radmedix, Llc2631%
Shantou Institute Of Ultrasonic Instruments Co., Ltd.1923%
Careray Digital Medical Technology Co., Ltd.810%
Aspen Imaging Healthcare Inc56%
Genoray Co., Ltd.56%
Remedi Co.,Ltd.45%
Sedecal45%
Livermoretech Inc34%

Top labelers

CompanyDevicesShare
Radmedix, Llc2631%
Shantou Institute Of Ultrasonic Instruments Co., Ltd.1923%
Careray Digital Medical Technology Co., Ltd.810%
Aspen Imaging Healthcare Inc56%
Genoray Co., Ltd.56%
Remedi Co.,Ltd.45%
Sedecal45%
Livermoretech Inc34%
Konica Minolta Medical Imaging U.S.A., Inc.34%
H&Abyz Co., Ltd22%
Ge Medical Systems, L.L.C.11%
Vsi Co., Ltd.11%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

X-ray Flat Panel DetectorX-ray Flat Panel DetectorsSIUIEUROPAAirTouchAirTouch, EZER, EUROPAAPX-24OptimaPortable X-Ray SystemRadmedix AcuityPDR+Radmedix AcuityPDRAcuityPDRGenorayCLAROX plusHnX-PBHnX-P1

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

FDA product codes

CodeNameDevices
IZLSystem, X-Ray, Mobile64
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)32
LLZSystem, Image Processing, Radiological19
EHDUnit, X-Ray, Extraoral With Timer6
IZISystem, X-Ray, Angiographic3
IZLSystem, x-ray, mobile1

GMDN & GCC registration

  • GMDN code 37643 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 49% · 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 portable basic diagnostic x-ray system, digital products are registered in the US?

83 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Portable basic diagnostic x-ray system, digital", from 14 companies. The largest labeler is Radmedix, Llc with 31% of records.

Which FDA product codes apply?

IZL (System, X-Ray, Mobile), MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), LLZ (System, Image Processing, Radiological), 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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