Agfa Computed Radiography Systems with Dx-G Digitizers

• • Terminated Z-0591-2012 FDA Unclassified (pre-2012) ·initiated 6 Dec 2011

  Occasionally images can be lost or sent to an incorrect folder or the digitizer may stop either during startup or during a cassette scan cycle.

• • Terminated Z-0464-2011 FDA Unclassified (pre-2012) ·initiated 8 Oct 2010

  Packaging was switched between a DX-G Digitizer and a DX-M Digitizer, resulting in the wrong product, which is not sold in the US, being shipped to the consignee.

510(k) Number

K092238 ↗

FDA Product Code

MQB

Device Class

Class II

Regulation

21 CFR Part 892.1680

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• ICIS View

  Class II

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• Dx-D 300

  Class II

  CE/MDR FDA 510(k) K103050 Active Cleared 29 Oct 2010

See all devices from Agfa Healthcare N.V. →