Agfa Computed Radiography Systems with Nx Workstations

• • Terminated Z-2735-2017 FDA Class II ·initiated 21 Dec 2016

  A customer reported that when using an NX workstation with software version NX 3.0.8950 software and selecting the affected patient/exam from closed exams, initially the wrong image was linked to the exam and appeared. After a short time the wrong image was replaced by the correct image, however the wrong image was used for transmitting to PACS.

• • Terminated Z-1889-2009 FDA Unclassified (pre-2012) ·initiated 22 Jun 2009 ·via K090672, on the same 510(k)

  After opening and closing a study on a Central Monitoring System while a study is still open on an in-room NX system, a problem of image mix-up can occur on the in-room NX system.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K090672 ↗

FDA Product Code

MQB

Device Class

Class II

Regulation

21 CFR Part 892.1680

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

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