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Device Explorer · FDA GUDID · GMDN 47816

Radiological video camera patient positioning/tracking system

An assembly of hardware and software devices intended to use light-based (e.g., infrared, visible light) image acquisition to create three-dimensional (3-D) surfaces of a patient anatomy (e.g., head) to monitor patient position during diagnostic imaging, radia

US‑registered devices93in commercial distribution
Companies5labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription91%Rx‑only share
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Share of device records

Vision Rt Limited7581%
L A P Gmbh Laser Applikationen1011%
Tracinnovations A/S44%
Diers International Gmbh33%
Brainlab Se11%

Top labelers

CompanyDevicesShare
Vision Rt Limited7581%
L A P Gmbh Laser Applikationen1011%
Tracinnovations A/S44%
Diers International Gmbh33%
Brainlab Se11%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TCL3 Motion Tracking SystemAlignRTAlignRT PlusMapRTDoseRT reference boardDoseRT cameraAlignRT 7.3 (software)LUNA 3DDIERS posturaDIERS staticoDIERS formetricExacTrac Dynamic

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

FDA product codes

CodeNameDevices
IYEAccelerator, Linear, Medical97
LNHSystem, Nuclear Magnetic Resonance Imaging5
KQXGoniometer, Ac-Powered3

GMDN & GCC registration

  • GMDN code 47816 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 91% · 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

Height (Millimeter) · 5Width (Millimeter) · 5Depth (Millimeter) · 5

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How many radiological video camera patient positioning/tracking system products are registered in the US?

93 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Radiological video camera patient positioning/tracking system", from 5 companies. The largest labeler is Vision Rt Limited with 81% of records.

Which FDA product codes apply?

IYE (Accelerator, Linear, Medical), LNH (System, Nuclear Magnetic Resonance Imaging), KQX (Goniometer, Ac-Powered)

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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