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Device Explorer · FDA GUDID · GMDN 40873

Ultrasound imaging system application software

"An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with su

US‑registered devices101in commercial distribution
Companies32labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription82%Rx‑only share
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Share of device records

Ge Vingmed Ultrasound A/S2222%
Amcad Biomed Corporation99%
Thd Spa99%
Qview Medical77%
Echonous, Inc.66%
Dia Imaging Analysis Ltd44%
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc44%
Ultrasight Ltd33%

Top labelers

CompanyDevicesShare
Ge Vingmed Ultrasound A/S2222%
Amcad Biomed Corporation99%
Thd Spa99%
Qview Medical77%
Echonous, Inc.66%
Dia Imaging Analysis Ltd44%
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc44%
Ultrasight Ltd33%
Brightheart33%
Philips Ds North America Llc33%
Verathon Inc33%
As Software, Llc33%

Company = labeler of record on GUDID. 32 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Clarius Ultrasound ScannerLvivo Standalone UILvivo SeamlessLvivo MobileLvivo Software Application PlatformPVAD IQUltraSight GuidanceEchoGoAmCAD UOAmCAD-USAmCAD UT DetectionFETOLYSonio DetectHepatoscopeB-Right Screen Fetal HeartB-Right Views Fetal Heart

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

FDA product codes

CodeNameDevices
IYOSystem, Imaging, Pulsed Echo, Ultrasonic42
QIHAutomated Radiological Image Processing Software26
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic23
ITXTransducer, Ultrasonic, Diagnostic22
LLZSystem, Image Processing, Radiological22
LLZSystem, image processing, radiological13

GMDN & GCC registration

  • GMDN code 40873 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 82% · 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 ultrasound imaging system application software products are registered in the US?

101 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ultrasound imaging system application software", from 32 companies. The largest labeler is Ge Vingmed Ultrasound A/S with 22% of records.

Which FDA product codes apply?

IYO (System, Imaging, Pulsed Echo, Ultrasonic), QIH (Automated Radiological Image Processing Software), IYN (System, Imaging, Pulsed Doppler, Ultrasonic), ITX (Transducer, Ultrasonic, Diagnostic)

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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