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Device Explorer · FDA GUDID · GMDN 61108

Indirect flat panel x-ray detector

An electrically-powered, cassette-like device intended to be used as part of an x-ray system to detect x-ray images following exposure, and create a digital signal; it is not dedicated to imaging of a specific anatomy. It includes two types of transducing tech

US‑registered devices365in commercial distribution
Companies29labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription74%Rx‑only share
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Share of device records

Carestream Health, Inc.5816%
Iray Group4813%
Drtech Corporation4312%
Rayence Co., Ltd.4011%
Konica Minolta, Inc.3610%
Vieworks Co., Ltd.216%
Iray Imaging Technology Taicang Limited164%
Agfa113%

Top labelers

CompanyDevicesShare
Carestream Health, Inc.5816%
Iray Group4813%
Drtech Corporation4312%
Rayence Co., Ltd.4011%
Konica Minolta, Inc.3610%
Vieworks Co., Ltd.216%
Iray Imaging Technology Taicang Limited164%
Agfa113%
Lg Electronics Inc.113%
Pixxgen Corporation103%
Samsung Electronics Co., Ltd.103%
Radisen Co., Ltd.92%

Company = labeler of record on GUDID. 29 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Mano4343W(k Taicang)iRay(k Taicang)Mano4336W(k Taicang)Mano4343W(k)iRay(k)Mano4336W(k)Mano4343WiRayMano4336WWireless digital flat panel detectorWireless Digital Flat Panel DetectorMano2530F Wireless Digital Flat Panel DetectorMano2530A Wireless Digital Flat Panel DetectorMano4343F Wireless Digital Flat Panel DetectorMano4343A Wireless Digital Flat Panel DetectorMano4336F Wireless Digital Flat Panel Detector

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

FDA product codes

CodeNameDevices
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)307
MQBSolid state x-ray imager (flat panel/digital imager)81
LLZSystem, Image Processing, Radiological5
JAASystem, X-Ray, Fluoroscopic, Image-Intensified5
MUEFull Field Digital, System, X-Ray, Mammographic4
MUEFull Field Digital,System,X-Ray,Mammographic2

GMDN & GCC registration

  • GMDN code 61108 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 74% · 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

Width (Centimeter) · 5Length (Centimeter) · 5Length (Millimeter) · 5Weight (Kilogram) · 5Width (Millimeter) · 5Depth (Millimeter) · 4

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

How many indirect flat panel x-ray detector 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 "Indirect flat panel x-ray detector", from 29 companies. The largest labeler is Carestream Health, Inc. with 16% of records.

Which FDA product codes apply?

MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), MQB (Solid state x-ray imager (flat panel/digital imager)), LLZ (System, Image Processing, Radiological), JAA (System, X-Ray, Fluoroscopic, Image-Intensified)

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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