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Advantage Paddle

by Livingston Products, Inc.

510(k) K033202

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 · Abbreviated NumberK033202 Date3 Dec 2003ClearedStatusActive

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  • Withdrawn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
IZH
Device Class
Class II
Regulation
21 CFR Part 892.1710
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 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 Advantage Paddle is a mammography system, classified as a Class II device. It is used in radiology for mammography procedures, aiming to improve patient comfort and provide better images. The device is substantially equivalent to other similar devices, such as the S.O.F.T. Paddle by American Mammographics, Inc.

The Advantage Paddle is supplied by Livingston Products, Inc. and has been cleared by the FDA under the 510(k) process, with the clearance number K033202. The device is regulated under 21 CFR 892.1710, with the product code IZH. It is intended for use in radiology and is subject to the applicable regulatory requirements.

Questions

AI-generated answers, 1 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 Advantage Paddle used for?

    The Advantage Paddle is used in radiology for mammography procedures to improve patient comfort and provide better images.

  • Is the Advantage Paddle a single-use or reusable device?

    The device data does not specify whether the Advantage Paddle is single-use or reusable, but it is intended for use in radiology settings.

  • What regulatory clearance does the Advantage Paddle have?

    The Advantage Paddle has been cleared by the FDA under the 510(k) process with clearance number K033202.

  • What product code does the Advantage Paddle have?

    The Advantage Paddle has the product code IZH and is regulated under 21 CFR 892.1710.