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Biopsy Positioner

by Fuji Film Medical Systems

510(k) K113284

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 · Traditional NumberK113284 Date7 Mar 2012ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2690-2016 FDA Class II initiated 9 Jun 2016 on shared 510(k) K113284

    If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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