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TRT Trans-Rectal Transducer

by Advanced Technology Laboratories, Inc.

510(k) K870038

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 NumberK870038 Date30 Mar 1987ClearedStatusActive

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  • Withdrawn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, 6 Oct 2026

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

The TRT Trans-Rectal Transducer is an ultrasonic diagnostic transducer used for medical imaging. It is designed to be inserted trans-rectally to provide ultrasound images of the prostate and surrounding tissues.

This device is supplied as a reusable transducer and requires appropriate storage conditions. It received FDA 510(k) clearance with product code ITX and was classified as Class II - Special Controls. The device is model K870038 and was cleared by Advanced Technology Laboratories, Inc.

Other devices from Advanced Technology Laboratories, Inc.

See all devices from Advanced Technology Laboratories, Inc. →

Questions

AI-generated answers, 6 Oct 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 TRT Trans-Rectal Transducer used for?

    The TRT Trans-Rectal Transducer is an ultrasonic diagnostic transducer designed for transrectal insertion to provide ultrasound images of the prostate and surrounding tissues for medical diagnostic purposes.

  • Is the TRT Trans-Rectal Transducer reusable or single-use?

    The TRT Trans-Rectal Transducer is supplied as a reusable transducer, which means it can be used multiple times following appropriate cleaning and storage protocols as specified by the manufacturer.

  • What are the regulatory approvals for the TRT Trans-Rectal Transducer?

    The TRT Trans-Rectal Transducer received FDA 510(k) clearance with product code ITX and was classified as Class II - Special Controls. It is model K870038 and was cleared by Advanced Technology Laboratories, Inc.

  • What storage conditions are required for the TRT Trans-Rectal Transducer?

    The TRT Trans-Rectal Transducer requires appropriate storage conditions as specified by the manufacturer to maintain its functionality and longevity, though specific storage details aren't provided in the available information.