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Aquilion CT Scanner, Model Tsx-101A

by Toshiba America Medical Systems, In.C

510(k) K982265

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 · Traditional NumberK982265 Date26 Aug 1998ClearedStatusActive

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1708-2008 FDA Unclassified (pre-2012) initiated 1 Oct 2007
    • Terminated Z-1707-2008 FDA Unclassified (pre-2012) initiated 1 Oct 2007

    Excessive radiation: Intermittent shifting of CT numbers causes the actual dose to the patient to be greater than expected, when Sure Exposure option is used.

    • Terminated Z-1031-04 FDA Unclassified (pre-2012) initiated 17 Mar 2004

    Erroneous patient data is entered. Previoius patient's demographics are recorded.

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  • Withdrawn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
JAK
Device Class
Class II
Regulation
21 CFR Part 892.1750
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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