Direct Digitizer Regius Model 370

• • Terminated Z-1481-06 FDA Unclassified (pre-2012) ·initiated 14 Jul 2006

  A hand grip column, even though locked in position, moved downward about 3 cm while a patient was holding the hand grip for lateral exposure. When the hand grip moved down, the patient who was holding it lost his or her balance and almost fell. This problem only occurred in Japan with one system.

510(k) Number

K051418 ↗

FDA Product Code

MQB

Device Class

Class II

Regulation

21 CFR Part 892.1680

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Reguis Sigma

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  Class II

  FDA 510(k) K071181 Active Cleared 30 May 2007

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  Class II

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  Class II

  FDA 510(k) K052095 Active Cleared 3 Nov 2005

• Regius Unitea

  Class II

  FDA 510(k) K071436 Active Cleared 27 Jun 2007

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