Skip to content

Celesteion, Pca-9000A/2

by Toshibamedical Systems Corporation

510(k) K140651

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 NumberK140651 Date11 Jun 2014ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1607-2016 FDA Class II initiated 24 Apr 2016

    Potential degradation of detector performance.

    • Terminated Z-0005-2016 FDA Class II initiated 8 May 2015

    It was found that if specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved due to a software problem.

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  • Withdrawn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
KPS
Device Class
Class II
Regulation
21 CFR Part 892.1200
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Toshiba Medical Systems

See all devices from Toshiba Medical Systems →