Neuro II-Se, Models or-Mb-Dr and or-Dr

• • Terminated Z-1098-2016 FDA Class II ·initiated 10 Feb 2016

  Emergency helium venting lines (i.e. quench lines) may not have been properly installed.

• • Terminated Z-0428-2013 FDA Class II ·initiated 19 Oct 2012

  IMRIS Inc. initiated a recall of their OR Tables ORT100 and ORT200. When proper procedure is not followed, the foot end of the IMRIS intra-operative OR table may be attracted to the MRI magnet as the magnet approaches the table. This poses a potential risk of injury to both the patient and operators standing near the table.

510(k) Number

K061916 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• SYMBIS Surgical System

  Class II

  FDA 510(k) K143420 Active Cleared 30 Oct 2015

• HFD100 Rocker Arm Accessory

  Class II

  FDA 510(k) K141950 Active Cleared 4 Sep 2014

• Ict

  Class II

  FDA 510(k) K130224 Active Cleared 18 Jul 2013

• Imrx

  Class II

  FDA 510(k) K091166 Active Cleared 2 Sep 2009

• Imrx System V1 and Imrisnv/Imriscardio Open recall

  Class II

  FDA 510(k) K101813 Active Cleared 5 Oct 2010

• Neuro III-Sv Open recall

  Class II

  FDA 510(k) K083137 Active Cleared 16 Dec 2008

See all devices from Imris, Inc. →