Device Explorer · FDA GUDID · GMDN 45143

PET/CT system

A diagnostic radiological imaging system that is a combination of a positron emission tomography (PET) camera system for nuclear medicine (NM) images, and a computed tomography (CT) camera system for x-ray images. The nuclear medicine images and the x-ray imag

US‑registered devices66in commercial distribution
Companies5labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription32%Rx‑only share
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Share of device records

Siemens Medical Solutions Usa, Inc.5177%
Shanghai United Imaging Healthcare Co., Ltd.914%
Canon Inc.23%
Philips Medical Systems Nederland B.V.23%
Uih Technologies Llc23%

Top labelers

CompanyDevicesShare
Siemens Medical Solutions Usa, Inc.5177%
Shanghai United Imaging Healthcare Co., Ltd.914%
Canon Inc.23%
Philips Medical Systems Nederland B.V.23%
Uih Technologies Llc23%

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

Brand names on the register (sample)

uMIuEXPLORERPET-CT SCANNERTOSHIBA SCANNERBiograph Trinion.X EP5 CT64Biograph Trinion.X EP9 CT64Biograph Trinion.X EP9 CT128Biograph Trinion.X EP5 CT128Biograph Vision.XBiograph Vision.X EdgeBiograph Trinion EP2 CT128Biograph Trinion EP CT128Biograph Trinion EP2 CT64Biograph Trinion EP CT64Biograph Vision QuadraBiograph Vision 450 Edge

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

FDA product codes

CodeNameDevices
KPSSystem, tomography, computed, emission53
KPSSystem, Tomography, Computed, Emission14
JAKSystem, X-Ray, Tomography, Computed14
JAKSystem, x-ray, tomography, computed6

GMDN & GCC registration

  • GMDN code 45143 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 32% · 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.

How many pet/ct system products are registered in the US?

66 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "PET/CT system", from 5 companies. The largest labeler is Siemens Medical Solutions Usa, Inc. with 77% of records.

Which FDA product codes apply?

KPS (System, tomography, computed, emission), KPS (System, Tomography, Computed, Emission), JAK (System, X-Ray, Tomography, Computed), JAK (System, x-ray, tomography, computed)

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.

How do I get quotes?

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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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