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510(k) K110717

KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM by Konica Minolta Medical & Graphic, Inc. — Product Code MUE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2011
Date Received
March 15, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Full Field Digital, System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1715
Review Panel
RA
Submission Type

Other clearances by Konica Minolta Medical & Graphic, Inc.

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  • K121109 — AERODR X70 (May 23, 2012)
  • K120477 — AEROSYNC FOR AERODR SYSTEM (April 9, 2012)
  • K120131 — REGIUS SIGMA2 (February 10, 2012)
  • K113248 — AERODR SYSTEM WITH P-21 (January 17, 2012)
  • K103703 — REGUIS SIGMA (June 2, 2011)
  • K101842 — ACIES (February 4, 2011)
  • K102349 — AERODR SYSTEM (November 24, 2010)

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