Regius Console Cs-2000 and Regius Console Cs-3000, Medical Image Processing Workstation

• • Terminated Z-0862-06 FDA Unclassified (pre-2012) ·initiated 6 Feb 2006

  If the patient demographic data is entered into the CS-1 manually, and the user fails to enter any data in one of the demographic data fields labeled as Birthday, Sex, Name or Patient Comments, etc, the RIM will populate the fields where no data has been entered with data from the previous patient.

510(k) Number

K051523 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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