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Ami Mammospot

by American Mammographics, Inc.

510(k) K903651

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 NumberK903651 Date15 Nov 1990ClearedStatusActive

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  • Withdrawn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, 21 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 AMI MAMMOSPOT is a Class II mammography system used in radiology. It is designed for breast imaging procedures.

The device is supplied by American Mammographics, Inc. and received FDA 510(k) clearance on November 15, 1990. It is regulated under product code IZH and regulation number 892.1710.

Other devices from American Mammographics, Inc.

Questions

AI-generated answers, 21 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 AMI MAMMOSPOT used for?

    The AMI MAMMOSPOT is a Class II mammography system specifically designed for breast imaging procedures in radiology settings. It is used to capture detailed images of breast tissue for diagnostic purposes.

  • How is the AMI MAMMOSPOT supplied?

    The AMI MAMMOSPOT is supplied by American Mammographics, Inc., located at 1302 Shawhan Ter., Chattanooga, TN 37411. The device is manufactured and distributed by this company.

  • What is the regulatory status of the AMI MAMMOSPOT?

    The AMI MAMMOSPOT received FDA 510(k) clearance on November 15, 1990, and is regulated under product code IZH and regulation number 892.1710. It is classified as a Class II device and was determined to be substantially equivalent.

  • Is the AMI MAMMOSPOT reusable or single-use?

    The device data does not specify whether the AMI MAMMOSPOT is reusable or single-use. For specific usage instructions regarding reprocessing or disposal, please refer to the manufacturer's documentation or contact American Mammographics, Inc.