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Device Explorer · FDA GUDID · GMDN 40771

Rectal/vaginal ultrasound imaging transducer

An invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. Sometimes referred to as an ultrasound probe,

US‑registered devices361in commercial distribution
Companies31labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription83%Rx‑only share
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Share of device records

Samsung Medison Co., Ltd.4512%
Siemens Medical Solutions Usa, Inc.3610%
Fujifilm Corporation349%
Fujifilm Sonosite, Inc.349%
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.319%
Canon Inc.257%
Sonoscape Medical Corp.236%
Chison Medical Technologies Co., Ltd.236%

Top labelers

CompanyDevicesShare
Samsung Medison Co., Ltd.4512%
Siemens Medical Solutions Usa, Inc.3610%
Fujifilm Corporation349%
Fujifilm Sonosite, Inc.349%
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.319%
Canon Inc.257%
Sonoscape Medical Corp.236%
Chison Medical Technologies Co., Ltd.236%
Medisono, Llc226%
Bk Medical Aps154%
Alpinion Medical Systems Co., Ltd.123%
Shantou Institute Of Ultrasonic Instruments Co., Ltd.103%

Company = labeler of record on GUDID. 31 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

WISONICSonoScapesonoscapeSonoscapeMicro convex probeline array probeVolume probeConvex probeLinear probe6LB7E Ultrasonic Probe(FDA)DE11-3s Ultrasonic Probe(FDA)E9-3 3D Curved Array TransdcuerDE10-3WU Ultrasonic Probe(FDA)E9-3 Endocavitary Tranducer 87444-0065EC10ED Probe (Wolf)65EC10EA Ultrasonic Transducer(FDA)

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, Diagnostic261
IYOSystem, Imaging, Pulsed Echo, Ultrasonic153
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic152
ITXTransducer, ultrasonic, diagnostic123
IYNSystem, imaging, pulsed doppler, ultrasonic44
IYOSystem, imaging, pulsed echo, ultrasonic31

GMDN & GCC registration

  • GMDN code 40771 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 83% · 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 rectal/vaginal ultrasound imaging transducer products are registered in the US?

361 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Rectal/vaginal ultrasound imaging transducer", from 31 companies. The largest labeler is Samsung Medison Co., Ltd. with 12% of records.

Which FDA product codes apply?

ITX (Transducer, Ultrasonic, Diagnostic), IYO (System, Imaging, Pulsed Echo, Ultrasonic), 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.

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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