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Tetrad Model TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP Transducers

by Tetrad Corp.

510(k) K014182

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK014182 Date3 Jan 2002ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2400-2025 FDA Class III initiated 3 Jul 2025

    To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

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  • Withdrawn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
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 892.1570
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Tetrad Model TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP Transducers are medical devices classified under product code ITX, designed for use in radiology applications. These transducers convert one form of energy to another, specifically in the context of medical imaging or diagnostic procedures.

The devices are supplied by Tetrad Corp. and have received FDA 510(k) clearance with the K number K014182, deemed substantially equivalent. The transducers are available in multiple model numbers including TC-C52-, -C84V-, -C95-, -CLA76-, and -L74-ATP, and are intended for use in clinical settings where such transducer technology is required.

Other devices from Tetrad Corp.

Questions

AI-generated answers, 25 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 are the Tetrad TC-C52- ATP Transducers used for?

    The Tetrad TC-C52- ATP Transducers are medical devices designed for radiology applications, converting one form of energy to another in the context of medical imaging or diagnostic procedures. They are available in multiple models including TC-C52-, -C84V-, -C95-, -CLA76-, and -L74-ATP.

  • How are the Tetrad TC-C52- ATP Transducers supplied?

    The transducers are supplied by Tetrad Corp. and are available in multiple model numbers including TC-C52-, -C84V-, -C95-, -CLA76-, and -L74-ATP. They are intended for use in clinical settings where such transducer technology is required.

  • What is the regulatory status of the Tetrad TC-C52- ATP Transducers?

    The Tetrad TC-C52- ATP Transducers have received FDA 510(k) clearance with the K number K014182, deemed substantially equivalent. They are classified under product code ITX and were reviewed by the Radiology advisory committee.

  • Are the Tetrad TC-C52- ATP Transducers single-use or reusable?

    The device data does not specify whether the Tetrad TC-C52- ATP Transducers are single-use or reusable. This information would need to be obtained directly from the manufacturer or product documentation.