Consulting Wallah › Device Explorer › Cardiovascular › Cardiovascular ultrasound imaging system
Device Explorer · FDA GUDID · GMDN 40763

Cardiovascular ultrasound imaging system

An assembly of mains electricity (AC-powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) imaging procedures involving the heart and blood vessels. Included are software packages that support a variety of static or

US‑registered devices243in commercial distribution
Companies13labelers on GUDID
Single‑use3%of device records
Sterile1%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Boston Scientific Corporation9037%
Ge Vingmed Ultrasound A/S5422%
Medistim Asa2711%
Ge Medical Systems (China) Co.,Ltd.2510%
Acist Medical Systems, Inc.146%
Philips Image Guided Therapy Corporation135%
Nipro Vascular Innovations Americas, Inc.62%
Volcano Corporation62%

Top labelers

CompanyDevicesShare
Boston Scientific Corporation9037%
Ge Vingmed Ultrasound A/S5422%
Medistim Asa2711%
Ge Medical Systems (China) Co.,Ltd.2510%
Acist Medical Systems, Inc.146%
Philips Image Guided Therapy Corporation135%
Nipro Vascular Innovations Americas, Inc.62%
Volcano Corporation62%
Provisio Medical, Inc.31%
G E Medical Systems Israel Ltd.21%
Jiangsu Tingsn Technology Co., Ltd.10%
Canon Inc.10%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Medistim System Activation CardMedistim MiraQ Ultimate SystemMedistim MiraQ Vascular SystemMedistim MiraQ Cardiac SystemColor Doppler Diagnostic Ultrasound SystemDIAGNOSTIC ULTRASOUND SYSTEMACUSON SC2000 Diagnostic Ultrasound SystemMakoto Intravascular Imaging System™TVC Imaging System™Makoto Integrated Intravascular Imaging System™SLT IVUS P1 CartSLT IVUS P1 Display UnitSLT IVUS P1 Pulser Receiver UnitPatient Interface Module (PIMr)IntraSight PlusIntraSight Mobile System

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

FDA product codes

CodeNameDevices
ITXTransducer, ultrasonic, diagnostic102
IYOSystem, imaging, pulsed echo, ultrasonic100
IYNSystem, imaging, pulsed doppler, ultrasonic75
IYOSystem, Imaging, Pulsed Echo, Ultrasonic74
DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE58
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic39

GMDN & GCC registration

  • GMDN code 40763 · non‑implantable
  • Single‑use 3% · sterile 1% · Rx‑only 97% · 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

Depth (Inch) · 3Height (Inch) · 3Width (Inch) · 3Weight (Pound) · 2Weight (Kilogram) · 1

Use these as the dimensions to specify in a tender line.

How many cardiovascular ultrasound imaging system products are registered in the US?

243 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardiovascular ultrasound imaging system", from 13 companies. The largest labeler is Boston Scientific Corporation with 37% of records.

Which FDA product codes apply?

ITX (Transducer, ultrasonic, diagnostic), IYO (System, imaging, pulsed echo, ultrasonic), IYN (System, imaging, pulsed doppler, ultrasonic), IYO (System, Imaging, Pulsed Echo, Ultrasonic)

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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