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Aquilion Prime, V6.00

by Toshibamedical Systems Corporation

510(k) K141741

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 NumberK141741 Date26 Nov 2014ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0622-2017 FDA Class II initiated 25 Oct 2016

    Toshiba American Medical Systems (TAMS) is recalling the Aquilion CT system because it has been reported that the cooling oil in the x-ray tube heat exchanger may leak during system operation.

    • Terminated Z-0018-2016 FDA Class II initiated 8 May 2015

    If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.

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  • Withdrawn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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