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Infx-8000V, V5.30

by Toshibamedical Systems Corporation

510(k) K133535

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 NumberK133535 Date23 Jul 2014ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0844-2018 FDA Class II initiated 29 Dec 2017

    During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.

    • Terminated Z-0752-2016 FDA Class II initiated 14 Aug 2015

    When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value to the software. Consequently, the software defined the data as an "abnormal value" and it stopped displaying dose data and the dose data was lost. The following message was displayed, "Dose meter abnormal, Dose info disabled".

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  • Withdrawn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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