Regius Unitea

• • Terminated Z-2282-2018 FDA Class II ·initiated 9 May 2018

  Panasonic has issued a Mandatory Product Safety Notice, indicating a possibility of battery ignition (fire) in CF-C2 "Toughbook" laptops. Since Konica Minolta uses this laptop in some of its product configurations, it notified its customers to utilize a BIOS Utility for the laptops to minimize the risk of an incident while Panasonic develops a final solution.

510(k) Number

K071436 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Reguis Sigma

  Class II

  FDA 510(k) K103703 Active Cleared 2 Jun 2011

• Direct Digitizer, Regius Model 110

  Class II

  FDA 510(k) K071181 Active Cleared 30 May 2007

• Konica Minolta Xpress Digital Mammography System

  Class II

  FDA 510(k) K110717 Active Cleared 23 Dec 2011

• Direct Digitizer, Regius Model 210

  Class II

  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

• Konica Direct Digitizer Regius Model 350

  Class II

  FDA 510(k) K013054 Active Cleared 1 Mar 2002

See all devices from Konica Minolta Medical & Graphic, Inc. →