DR 800 with MUSICA Dynamic

• • Ongoing Z-2738-2024 FDA Class II ·initiated 29 Jul 2024

  Potential for the front lever chain of the DR 800 table to fail.

• • Terminated Z-2202-2020 FDA Class II ·initiated 6 Apr 2020

  Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible

• • Terminated Z-2056-2019 FDA Class II ·initiated 27 Jun 2019

  The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.

510(k) Number

K180589 ↗

FDA Product Code

JAA

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• DX-D Imaging Package

  Class II

  FDA 510(k) K172784 Active Cleared 13 Oct 2017

• 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

• Dx-D 300

  Class II

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

See all devices from Agfa Healthcare N.V. →