Mammograph III

by American Medical Imports, Inc.

510(k) K844119

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

510(k) K844119↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK844119	Date19 Jul 1985Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K844119
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, 19 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 Mammograph III is a Class II mammographic X-ray system, designed for digital or analog imaging of breast tissue. It employs low-dose X-ray technology to produce detailed images for the detection and diagnosis of breast cancer and other abnormalities, adhering to radiologic standards for breast imaging.

This device is intended for use in radiology departments and is supplied as a reusable medical system. It requires FDA 510(k) clearance (K844119) and is classified under product code IZH, regulated under 21 CFR 892.1710. The Mammograph III is not single-use and must be maintained according to manufacturer guidelines to ensure proper function and safety.