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Device Explorer · FDA GUDID · GMDN 40770

Surgical ultrasound imaging transducer

A hand-held ultrasound imaging transducer assembly designed to be positioned within a surgical site for localized intraoperative imaging applications. It is sometimes referred to as a surgical probe or fingertip probe. It steers, focuses, and detects the ultra

US‑registered devices161in commercial distribution
Companies18labelers on GUDID
Single‑use1%of device records
Sterile1%labelled sterile
Prescription83%Rx‑only share
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Share of device records

Fujifilm Corporation5534%
Bk Medical Aps2012%
Medisono, Llc149%
Fujifilm Sonosite, Inc.127%
Canon Inc.117%
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.96%
Esaote Spa74%
Fujifilm Healthcare Americas Corporation64%

Top labelers

CompanyDevicesShare
Fujifilm Corporation5534%
Bk Medical Aps2012%
Medisono, Llc149%
Fujifilm Sonosite, Inc.127%
Canon Inc.117%
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.96%
Esaote Spa74%
Fujifilm Healthcare Americas Corporation64%
Ge Healthcare Japan Corporation64%
Sonoscape Medical Corp.53%
Philips Ultrasound Llc42%
Humanscan Co.,Ltd32%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

sonoscapeSonoscapeSonoScapeC9-3sp Curved Array TransducerL14-5sp Linear Array Tranducer 84008-3075LT38EA Ultrasonic Transducer(FDA)7LT4 Ultrasonic Transducer(FDA)7LT4s Ultrasonic Transducer(FDA)L14-5sp Ultrasonic Probe(FDA)7LT4P Ultrasonic Transducer(FDA)C12-4lp Laparoscope Transducer 89200-00L16-4Hs Transducer(FDA-SJM)I13C3fx TransducerRob12C4N20P6 TransducerBurr-Hole Transducer

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, Diagnostic178
IYOSystem, Imaging, Pulsed Echo, Ultrasonic134
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic130
ITXTransducer, ultrasonic, diagnostic37
IYNSystem, imaging, pulsed doppler, ultrasonic23
IYOSystem, imaging, pulsed echo, ultrasonic13

GMDN & GCC registration

  • GMDN code 40770 · non‑implantable
  • Single‑use 1% · sterile 1% · 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 surgical ultrasound imaging transducer products are registered in the US?

161 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical ultrasound imaging transducer", from 18 companies. The largest labeler is Fujifilm Corporation with 34% 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.

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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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