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Device Explorer · FDA GUDID · GMDN 37618

Full-body CT system

An assembly of diagnostic x-ray computed tomography (CT) devices with a gantry large enough to allow imaging of any part of the body. It includes designs with single or multiple fixed annular arrays of x-ray tubes and opposing detectors or those with x-ray tub

US‑registered devices306in commercial distribution
Companies22labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription56%Rx‑only share
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Share of device records

Siemens Healthcare Gmbh12340%
Ge Hangwei Medical Systems Company Ltd.3311%
Philips Medical Systems Nederland B.V.227%
Ge Medical Systems, L.L.C.227%
Ge Medical Systems Israel, Functional Imaging227%
Siemens Shanghai Medical Equipment Ltd.207%
Canon Inc.186%
Philips Healthcare (Suzhou) Co., Ltd.72%

Top labelers

CompanyDevicesShare
Siemens Healthcare Gmbh12340%
Ge Hangwei Medical Systems Company Ltd.3311%
Philips Medical Systems Nederland B.V.227%
Ge Medical Systems, L.L.C.227%
Ge Medical Systems Israel, Functional Imaging227%
Siemens Shanghai Medical Equipment Ltd.207%
Canon Inc.186%
Philips Healthcare (Suzhou) Co., Ltd.72%
Shanghai United Imaging Healthcare Co., Ltd.62%
Ge Healthcare Japan Corporation62%
Neusoft Medical Systems Co., Ltd.41%
Uih Technologies Llc41%

Company = labeler of record on GUDID. 22 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SpotLight DuoSpotLightCardioGrapheuCTNeuViz 128 Multi-Slice CT Scanner SystemNeuViz 16 Essence Multi-Slice CT Scanner SystemNeuViz 128 Multi-slice CT Scanner SystemNeuViz 64 Multi-slice CT Scanner SystemCT SCANNERAquilion Serve SPAquilion ONEAquilion Exceed LBTOSHIBA SCANNERFCT iStreamSCENARIA ViewSupria

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

FDA product codes

CodeNameDevices
JAKSystem, x-ray, tomography, computed244
JAKSystem, X-Ray, Tomography, Computed65
KPSSystem, tomography, computed, emission26
KPSSystem, Tomography, Computed, Emission3
IZZTable, radiographic, non-tilting, powered2
LLZSystem, Image Processing, Radiological1

GMDN & GCC registration

  • GMDN code 37618 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 56% · 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 full-body ct system products are registered in the US?

306 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Full-body CT system", from 22 companies. The largest labeler is Siemens Healthcare Gmbh with 40% of records.

Which FDA product codes apply?

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

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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