Skip to content

UST-974-5 Convex Transducer

by GE Medical Systems Information Technologies 2 variants

510(k) K911309

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK911309 Date29 Apr 1991ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
ITX
Device class
Class II
Regulation
21 CFR Part 892.1570
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The UST-974-5 Convex Transducer is a diagnostic ultrasound probe classified under the nomenclature for convex array transducers. It emits high-frequency sound waves to generate real-time images of internal body structures, primarily used in radiology for abdominal, vascular, and obstetric evaluations. Its curved design facilitates broader field-of-view imaging, enhancing visualization of soft tissues and organs.

This device is supplied as a reusable component for ultrasound systems and requires proper cleaning and disinfection between uses to maintain sterility and functionality. It is intended for use in clinical radiology settings and has been cleared by the FDA under 510(k) with K-number K911309, filed in 1991. No additional regulatory markings or MRI safety classifications are specified in the available data.

Other devices from GE Medical Systems Information Technologies, Inc.

See all devices from GE Medical Systems Information Technologies, Inc. →