Impax Next Generation

• • Terminated Z-0101-2019 FDA Class II ·initiated 3 Aug 2018

  Adding an additional comparison study to the Clinical Side Bar in the Enterprise Imaging Diagnostics Desktop, can result in a change of the sort order of the studies in the Clinical Side Bar. The thumbnail images of the studies are no longer chronologically sorted with the most recent study at the top.

• • Terminated Z-0919-2014 FDA Class II ·initiated 8 Jan 2014

  Patient name displayed (printed) on the Patient Report was the wrong patient name.

510(k) Number

K111945 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• DX-D Imaging Package

  Class II

  FDA 510(k) K172784 Active Cleared 13 Oct 2017

• DR 800 with MUSICA Dynamic Open recall

  Class II

  FDA 510(k) K180589 Active Cleared 5 Apr 2018

• ICIS View

  Class II

  FDA 510(k) K143397 Active Cleared 1 Jun 2015

• IMPAX Agility

  Class II

  FDA 510(k) K142316 Active Cleared 6 Jan 2015

• Agfa Computed Radiography Systems with Dx-G Digitizers

  Class II

  FDA 510(k) K092238 Active Cleared 11 Aug 2009

• IMPAX Volume Viewing 4.0

  Class II

  FDA 510(k) K161061 Active Cleared 22 Jun 2016

See all devices from Agfa Healthcare N.V. →