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Device Explorer · FDA GUDID · GMDN 37649

Portable general-purpose fluoroscopic x-ray system, digital

A portable (moveable from one location to another, and easily reassembled) general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a vari

US‑registered devices69in commercial distribution
Companies8labelers on GUDID
Single‑use6%of device records
Sterile6%labelled sterile
Prescription77%Rx‑only share
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Share of device records

Medtronic Navigation, Inc.3754%
Genoray Co., Ltd.1014%
Ziehm-Orthoscan, Inc.913%
Siemens Healthcare Gmbh69%
Siemens Shanghai Medical Equipment Ltd.23%
Globus Medical, Inc.23%
Hologic, Inc.23%
Skanray Technologies Limited11%

Top labelers

CompanyDevicesShare
Medtronic Navigation, Inc.3754%
Genoray Co., Ltd.1014%
Ziehm-Orthoscan, Inc.913%
Siemens Healthcare Gmbh69%
Siemens Shanghai Medical Equipment Ltd.23%
Globus Medical, Inc.23%
Hologic, Inc.23%
Skanray Technologies Limited11%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CIARTIC MoveCIOS SELECTCios FlowCios SpinCios AlphaCios SelectCios FusionO-arm O2O-armTM O2 Imaging SystemO-armO-ARM®NAN/AO-arm ™ TrackersO-ArmEXCELSIUS3D

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

FDA product codes

CodeNameDevices
OXOImage-intensified fluoroscopic x-ray system, mobile38
OWBInterventional fluoroscopic x-ray system31
JAASystem, X-Ray, Fluoroscopic, Image-Intensified18
OXOImage-Intensified Fluoroscopic X-Ray System, Mobile12
JAASystem, x-ray, fluoroscopic, image-intensified10
OWBInterventional Fluoroscopic X-Ray System10

GMDN & GCC registration

  • GMDN code 37649 · non‑implantable
  • Single‑use 6% · sterile 6% · Rx‑only 77% · 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

Weight (Kilogram) · 1

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

How many portable general-purpose fluoroscopic x-ray system, digital products are registered in the US?

69 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Portable general-purpose fluoroscopic x-ray system, digital", from 8 companies. The largest labeler is Medtronic Navigation, Inc. with 54% of records.

Which FDA product codes apply?

OXO (Image-intensified fluoroscopic x-ray system, mobile), OWB (Interventional fluoroscopic x-ray system), JAA (System, X-Ray, Fluoroscopic, Image-Intensified), OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)

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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