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Digital Radiography System, Model Dfp-8000D

by Toshiba America Medical Systems, In.C

510(k) K013608

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK013608 Date15 Nov 2001ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0532-06 FDA Unclassified (pre-2012) initiated 15 Nov 2005 on shared 510(k) K013608

    In certain conditions the FOV of the lateral plane does not coincide with the X-ray exposed area, and consequently a part of the X-ray field may not be displayed in the magnification mode.

    • Terminated Z-1337-04 FDA Unclassified (pre-2012) initiated 18 Jun 2004 on shared 510(k) K013608

    Defect in the mirroring unit.

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  • Withdrawn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
OWB
Device Class
Class II
Regulation
21 CFR Part 892.1650
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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