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Mammographic X-Ray Unit

by Lorad Corp.

510(k) K945496

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 NumberK945496 Date27 Dec 1994ClearedStatusActive

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  • Withdrawn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, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A mammographic X-ray unit is a system used for producing radiographic images of the breast. It is classified as a Class II medical device under FDA regulation 892.1710 and falls within the radiology specialty.

This device received traditional 510(k) clearance (K945496) from the FDA on December 27, 1994, following submission on November 8, 1994. It is manufactured by Lorad Corp. and is intended for use in radiology settings for breast imaging.

Other devices from Lorad Corp.

See all devices from Lorad Corp. →

Questions

AI-generated answers, 27 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 MAMMOGRAPHIC X-RAY UNIT used for?

    The MAMMOGRAPHIC X-RAY UNIT is a system used for producing radiographic images of the breast, intended for use in radiology settings for breast imaging as specified in its FDA 510(k) clearance.

  • Who manufactures the MAMMOGRAPHIC X-RAY UNIT and what is its FDA clearance number?

    The MAMMOGRAPHIC X-RAY UNIT is manufactured by Lorad Corp. and received traditional 510(k) clearance from the FDA under number K945496, following submission on November 8, 1994 and clearance on December 27, 1994.

  • What regulatory classification does the MAMMOGRAPHIC X-RAY UNIT have?

    The MAMMOGRAPHIC X-RAY UNIT is classified as a Class II medical device under FDA regulation 892.1710, which governs mammographic X-ray systems, and falls within the radiology specialty.