Infx-8000H, Infinix-I

• • Terminated Z-0845-2018 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-0331-2012 FDA Unclassified (pre-2012) ·initiated 3 Oct 2011 ·on shared 510(k) K082830

  The recall was initiated because Toshiba has confirmed that during patient transfer from a gurney to the catherization table, the tabletop may rotate unexpectedly when sufficient force is applied to the tabletop. The result of the tabletop rotating unexpectedly is the patient being tranferred may fall from the tabletop.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K082830 ↗

FDA Product Code

JAA

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Cstc-002A, Extended Field of View Software Option

  Class II

  FDA 510(k) K063241 Active Cleared 9 Nov 2006

• Famio Diagnostic Ultrasound Systems, Model Ssa-530A

  Class II

  FDA 510(k) K051500 Active Cleared 17 Jun 2005

• Aplio Xg Diagnostic Ultrasound System Model Ssa-790A Version 4.0

  Class II

  FDA 510(k) K091295 Active Cleared 15 May 2009

• Real-Time Reconstruction System Model Tsxf-001A

  Class II

  FDA 510(k) K950972 Active Cleared 15 Apr 1996

• Qd Knee/Foot Coil, Model Mjqj-147A

  Class II

  FDA 510(k) K051763 Active Cleared 14 Jul 2005

• Ssa-390A/Power Vision 8000

  Class II

  FDA 510(k) K991858 Active Cleared 16 Jun 1999

See all devices from Toshiba America Medical Systems, In.C →