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Device Explorer · FDA GUDID · GMDN 35580

Diagnostic-imaging multiformat camera

An electrically-powered camera-based imaging unit, typically using laser scanning techniques, that is designed to capture digital images created using diagnostic imaging systems, e.g., computed tomography (CT), magnetic resonance imaging (MRI), positron emissi

US‑registered devices139in commercial distribution
Companies6labelers on GUDID
Single‑use9%of device records
Sterile0%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Sopro7957%
Fujifilm Corporation2115%
Codonics Inc.1712%
Konica Minolta, Inc.96%
Carestream Health, Inc.96%
Fluoptics43%

Top labelers

CompanyDevicesShare
Sopro7957%
Fujifilm Corporation2115%
Codonics Inc.1712%
Konica Minolta, Inc.96%
Carestream Health, Inc.96%
Fluoptics43%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DRYPRO MODEL 873DRYPRO SIGMA 2DRYPRO SIGMADRYPRO MODEL 832DRYPIX SmartFUJI MEDICAL DRY FILMFilm TrayMagazine LMagazine SDRYPIX LiteDRYPIX PlusOWANDYACTEONCodonics Horizon® Operating SoftwareCodonics Horizon® Multi-media ImagerCodonics Horizon® XL Multi-media Imager

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

FDA product codes

CodeNameDevices
NYHPlaque Disclosing Kit67
LMCCamera, multi format, radiological32
LMCCamera, Multi Format, Radiological26
NBLLaser,Fluorescence Caries Detection12
OWNConfocal Optical Imaging4
QDGParathyroid Autofluorescence Imaging Device1

GMDN & GCC registration

  • GMDN code 35580 · non‑implantable
  • Single‑use 9% · sterile 0% · Rx‑only 100% · 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.

No closely related category with 50+ devices.

How many diagnostic-imaging multiformat camera products are registered in the US?

139 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Diagnostic-imaging multiformat camera", from 6 companies. The largest labeler is Sopro with 57% of records.

Which FDA product codes apply?

NYH (Plaque Disclosing Kit), LMC (Camera, multi format, radiological), LMC (Camera, Multi Format, Radiological), NBL (Laser,Fluorescence Caries Detection)

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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