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Device Explorer · FDA GUDID · GMDN 40943

Radiology picture archiving and communication system workstation

A freestanding, image processing device that is a component of a picture archiving and communication system (PACS) for radiology designed to be networked with a wide variety of diagnostic imaging systems [e.g., x-ray, nuclear medicine, magnetic resonance imagi

US‑registered devices357in commercial distribution
Companies36labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription69%Rx‑only share
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Share of device records

Barco Nv8624%
Sectra Ab4111%
Shenzhen Beacon Display Technology Co., Ltd.339%
Merge Healthcare Solutions Inc.267%
Philips Medical Systems Nederland B.V.247%
Chili Gmbh226%
Mirada Medical Limited216%
Ramsoft Inc164%

Top labelers

CompanyDevicesShare
Barco Nv8624%
Sectra Ab4111%
Shenzhen Beacon Display Technology Co., Ltd.339%
Merge Healthcare Solutions Inc.267%
Philips Medical Systems Nederland B.V.247%
Chili Gmbh226%
Mirada Medical Limited216%
Ramsoft Inc164%
Three Palm Software144%
Foresight Imaging, Llc103%
Sentiar, Inc.62%
Ebm Technologies Incorporated51%

Company = labeler of record on GUDID. 36 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Ventripoint Medical System Plus (VMS+)Sectra Orthopedic PackageSectra WorkstationSectra Workstation IDS7BioTraceIO VisionBioTraceIO 360BioTraceIO PrecisionOrpheus SystemBeaconBarcoNio 5.8MP GrayNio 5.8MP ColorNio Color 3MPNio Color 2MPCoronis Fusion 6MPCoronis Fusion 4MP

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

FDA product codes

CodeNameDevices
LLZSystem, Image Processing, Radiological397
PGYDisplay, Diagnostic Radiology81
LLZSystem, image processing, radiological67
PGYDisplay, diagnostic radiology42
LMDSystem, Digital Image Communications, Radiological12
OUGMedical Device Data System5

GMDN & GCC registration

  • GMDN code 40943 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 69% · OTC 1%
  • 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 radiology picture archiving and communication system workstation products are registered in the US?

357 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Radiology picture archiving and communication system workstation", from 36 companies. The largest labeler is Barco Nv with 24% of records.

Which FDA product codes apply?

LLZ (System, Image Processing, Radiological), PGY (Display, Diagnostic Radiology), LLZ (System, image processing, radiological), PGY (Display, diagnostic radiology)

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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