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Device Explorer · FDA GUDID · GMDN 44823

Digital imaging cassette

A device intended to be used in diagnostic x-ray imaging to hold and shield a phosphor plate (not included) from exposure to room light during transport and insertion into a computed radiography (CR) scanner to produce a digital image of a patient radiation pa

US‑registered devices129in commercial distribution
Companies9labelers on GUDID
Single‑use51%of device records
Sterile0%labelled sterile
Prescription84%Rx‑only share
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Share of device records

Premium Plus (Dongguan) Limited4837%
Agfa4031%
Konica Minolta, Inc.1612%
Maxill, Inc.129%
Dental Basics Inc.65%
Radlink, Inc.22%
Konica Minolta Medical Imaging U.S.A., Inc.22%
Carestream Health, Inc.22%

Top labelers

CompanyDevicesShare
Premium Plus (Dongguan) Limited4837%
Agfa4031%
Konica Minolta, Inc.1612%
Maxill, Inc.129%
Dental Basics Inc.65%
Radlink, Inc.22%
Konica Minolta Medical Imaging U.S.A., Inc.22%
Carestream Health, Inc.22%
Air Techniques, Inc.11%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CR HD5.0S GENERAL CASSETTECR MD1.0F GENERAL CASSETTECR MD1.0 GENERAL CASSETTECR MD4.1 FLFS CASSETTECR MD4.0T GENERAL CASSETTECR MD4.0R FLFS CASSETTECR MD4.0R GENERAL CASSETTECR MD4.0R GENERAL CASSETTE SRCR MD4.0T FLFS CASSETTECR HD5.0 AEC CASSETTECR HD5.0 FLFS CASSETTECR MD4.0 GENERAL CASSETTECR MM3.0 EXTREMITIES CASSETTEREGIUS CassetteRadlink CassettePHOSPHOR PLATE BARRIER ENVELOPES

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

FDA product codes

CodeNameDevices
PEMDental Barriers And Sleeves63
MQBSolid state x-ray imager (flat panel/digital imager)37
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)20
MUEFull field digital,system,x-ray,mammographic3
NRDUnit, Operative Dental, Accessories3
IWZFilm, Radiographic1

GMDN & GCC registration

  • GMDN code 44823 · non‑implantable
  • Single‑use 51% · sterile 0% · Rx‑only 84% · 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

Length (Centimeter) · 38Width (Centimeter) · 38Length (Inch) · 2Width (Inch) · 2

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

How many digital imaging cassette products are registered in the US?

129 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Digital imaging cassette", from 9 companies. The largest labeler is Premium Plus (Dongguan) Limited with 37% of records.

Which FDA product codes apply?

PEM (Dental Barriers And Sleeves), MQB (Solid state x-ray imager (flat panel/digital imager)), MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), MUE (Full field digital,system,x-ray,mammographic)

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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