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Liberty 9000 8-Ch Breast Coil with Disposable Biopsy Plate

by USA Instruments, Inc.

510(k) K041695

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 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 NumberK041695 Date23 Jul 2004ClearedStatusActive

Recalls

5 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0516-2007 FDA Unclassified (pre-2012) initiated 31 Jan 2007
    • Terminated Z-0517-2007 FDA Unclassified (pre-2012) initiated 31 Jan 2007
    • Terminated Z-0518-2007 FDA Unclassified (pre-2012) initiated 31 Jan 2007

    The packaging used for the Breast Biopsy plate may exhibit small holes or tears

  • 2 recalls, same reason

    • Terminated Z-0519-2007 FDA Unclassified (pre-2012) initiated 31 Jan 2007
    • Terminated Z-0505-2007 FDA Unclassified (pre-2012) initiated 21 Nov 2006

    The packaging used for the Breast Biopsy plate may exhibit small holes or tears.

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  • Withdrawn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
LNH
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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