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7.5 Mhz Pediatric Transesophageal Echo (Tee) Trans

by Siemens Ultrasound, Inc.

510(k) K910529

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK910529 Date15 Mar 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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, 27 Sep 2026

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

This device is a 7.5 MHz pediatric transesophageal echo (TEECHO (TEE) transducer, which is an ultrasound system designed for imaging cardiac structures via transesophageal approach in pediatric patients. It operates at a frequency of 7.5 MHz and is intended for diagnostic ultrasound imaging.

The device is supplied as a reusable transducer and is used in radiology settings. It received FDA 510(k) clearance under K910529 on March 15, 1991, and is classified as a Class II medical device with product code ITX. No claims about sterility, single-use status, MRI safety, sizes, storage, or additional authorizations are made beyond what is explicitly stated in the data.

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Questions

AI-generated answers, 27 Sep 2026

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

  • What is the 7.5 MHz Pediatric TEE Transducer used for?

    It is designed for diagnostic ultrasound imaging of cardiac structures in pediatric patients using a transesophageal approach, allowing clinicians to visualize heart anatomy and function from within the esophagus for detailed assessment.

  • Is the 7.5 MHz Pediatric TEE Transducer reusable or single-use?

    The device is supplied as a reusable transducer, meaning it is intended for multiple uses after proper cleaning and disinfection between patients, in accordance with the manufacturer’s reprocessing instructions.

  • What regulatory pathway was used for the 7.5 MHz Pediatric TEE Transducer?

    The device received FDA 510(k) clearance under submission K910529 on March 15, 1991, demonstrating substantial equivalence to a legally marketed predicate device, and is classified as a Class II medical device with product code ITX.