Skip to content

3T Hd Breast Array

by USA Instruments, Inc. United States 510(k)

510(k) K052585

Product code MOS

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK052585 Date4 Oct 2005ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls

5 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0516-2007 FDA Unclassified (pre-2012) initiated 31 Jan 2007 via K052585, on the same 510(k)
    • Terminated Z-0517-2007 FDA Unclassified (pre-2012) initiated 31 Jan 2007 via K052585, on the same 510(k)
    • Terminated Z-0518-2007 FDA Unclassified (pre-2012) initiated 31 Jan 2007 via K052585, on the same 510(k)

    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 via K052585, on the same 510(k)
    • Terminated Z-0505-2007 FDA Unclassified (pre-2012) initiated 21 Nov 2006 via K052585, on the same 510(k)

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

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
MOS
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from USA Instruments, Inc.

See all devices from USA Instruments, Inc. →

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K052585 24 fields · synced 22 Oct 2026