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Profile 2000 Mammography System PRO-2000

by Trex Medical Corp.

510(k) K984092

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 NumberK984092 Date5 Feb 1999ClearedStatusActive

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  • Withdrawn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, 26 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 Profile 2000 Mammography System, Pro-2000 is a dedicated mammographic imaging system used as an x-ray source in the performance of mammographic examinations. It is classified as a System, X-ray, Mammographic under product code IZH and is substantially equivalent to a predicate device.

The system is adaptable to performing screening and/or biopsy procedures with the addition of either a film-based or digital-based image receptor device. It received FDA 510(k) clearance (K984092) on February 5, 1999, and is manufactured by Trex Medical Corp. in Copiague, NY.

Other devices from Trex Medical Corp.

Questions

AI-generated answers, 26 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 Profile 2000 Mammography System, Pro-2000 used for?

    It is used as an x-ray source in the performance of mammographic examinations, including screening and biopsy procedures when paired with a film-based or digital-based image receptor device.

  • How is the Profile 2000 Mammography System supplied or configured for use?

    The system is adaptable to performing screening and/or biopsy procedures with the addition of either a film-based or digital-based image receptor device, allowing flexibility based on clinical needs.

  • What regulatory pathway was used for the Profile 2000 Mammography System, Pro-2000?

    It received FDA 510(k) clearance (K984092) on February 5, 1999, based on a determination of substantial equivalence to a predicate device under product code IZH.