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Konica Minolta Medical & Graphic, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
27
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K130936AERODR SYSTEM WITH P-31August 22, 2013
K123499AEROPILOTDecember 20, 2012
K120752AERODR STITCHING SYSTEMJune 8, 2012
K121109AERODR X70May 23, 2012
K120477AEROSYNC FOR AERODR SYSTEMApril 9, 2012
K120131REGIUS SIGMA2February 10, 2012
K113248AERODR SYSTEM WITH P-21January 17, 2012
K110717KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEMDecember 23, 2011
K103703REGUIS SIGMAJune 2, 2011
K101842ACIESFebruary 4, 2011
K102349AERODR SYSTEMNovember 24, 2010
K092717DIRECT DIGITIZER, REGIUS MODEL 210October 30, 2009
K081637LASER IMAGER DRYPRO MODEL 873July 1, 2008
K071436REGIUS UNITEAJune 27, 2007
K071181DIRECT DIGITIZER, REGIUS MODEL 110May 30, 2007
K061999DRY LASER IMAGER, DRYPRO MODEL 832August 15, 2006
K053173DS CASSETTEDecember 15, 2005
K051998REGIUS MODEL 170 DIRECT DIGITIZERNovember 3, 2005
K052095MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190November 3, 2005
K051523REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATIONJuly 20, 2005