Dx-D 600

• • Terminated Z-0692-2019 FDA Class II ·initiated 4 Dec 2018

  After an upgrade of the software of the Overhead Tube Crane, there were isolated cases in which the Overhead Tube Crane movement does not stop when the movement button is released. Instead of stopping while the movement button is released, the Tube Head Crane moves to the intended position.

• • Terminated Z-3245-2018 FDA Class II ·initiated 15 Aug 2018

  A supplier for the Agfa system noted a potential for the steel support cables of a similar device to break. This led to a mandatory review of all systems, changing the pulley and cables if any deterioration in the cables or irregular or excessive pulley wear. If the two cables that support the equipment to its roof anchor break, the equipment might fall and cause harm to the patient, or others.

• • Terminated Z-1738-2017 FDA Class II ·initiated 2 May 2016

  One of the dent markers from the DX-D600 dropped down from the overhead rail.

• • Terminated Z-2175-2014 FDA Class II ·initiated 2 Jul 2014

  Some customers reported that while using the DX-D600 in room or exam preparation, the Overhead Tube Crane (OTC) showed increased velocity and uncontrolled longitudinal movement.

510(k) Number

K112670 ↗

FDA Product Code

KPR

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

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  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. →