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Mammospot Paddle

by American Mammographics, Inc.

510(k) K954521

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 NumberK954521 Date24 Oct 1995ClearedStatusActive

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  • Withdrawn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, 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 Mammospot Paddle is a mammographic X-ray system component designed for use in radiology. It functions as part of a mammography system to assist in the imaging process.

This device is manufactured by American Mammographics, Inc. and has received FDA 510(k) clearance. It is classified as a Class II medical device under regulation number 892.1710.

Other devices from American Mammographics, Inc.

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 is the primary function of the Mammospot Paddle?

    The Mammospot Paddle is a component designed for use within a mammographic X-ray system. It serves to assist in the imaging process during mammography procedures.

  • What is the regulatory classification of this device?

    The Mammospot Paddle is classified as a Class II medical device under regulation number 892.1710. It has received FDA 510(k) clearance under the K-number K954521.

  • Who is the manufacturer of the Mammospot Paddle?

    This device is manufactured by American Mammographics, Inc., located in Chattanooga, Tennessee.