Konica Direct Digitizer Regius Model 350

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K013054 ↗

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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  FDA 510(k) K103703 Active Cleared 2 Jun 2011

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  FDA 510(k) K071181 Active Cleared 30 May 2007

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  Class II

  FDA 510(k) K110717 Active Cleared 23 Dec 2011

• Direct Digitizer, Regius Model 210

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  FDA 510(k) K092717 Active Cleared 30 Oct 2009

• Direct Digitizer Regius Model 190

  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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