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Modified M-IV Mammography System

by Lorad, A Hologic Co.

510(k) K011987

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

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 · Special NumberK011987 Date11 Jul 2001ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-1701-2014 FDA Class II initiated 13 May 2014

    Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury

  • 2 recalls, same reason

    • Terminated Z-0148-04 FDA Unclassified (pre-2012) initiated 14 Jan 2004
    • Terminated Z-0149-04 FDA Unclassified (pre-2012) initiated 14 Jan 2004

    System failed to meet the mA's accuracy specfications at low mA's values

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  • Withdrawn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

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