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510(k) K130936

AERODR SYSTEM WITH P-31 by Konica Minolta Medical & Graphic, Inc. — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2013
Date Received
April 4, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

Other clearances by Konica Minolta Medical & Graphic, Inc.

  • K123499 — AEROPILOT (December 20, 2012)
  • K120752 — AERODR STITCHING SYSTEM (June 8, 2012)
  • 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)
  • K110717 — KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM (December 23, 2011)
  • K103703 — REGUIS SIGMA (June 2, 2011)
  • K101842 — ACIES (February 4, 2011)
  • K102349 — AERODR SYSTEM (November 24, 2010)

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