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510(k) K113248

AERODR SYSTEM WITH P-21 by Konica Minolta Medical & Graphic, Inc. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2012
Date Received
November 3, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

Other clearances by Konica Minolta Medical & Graphic, Inc.

  • K130936 — AERODR SYSTEM WITH P-31 (August 22, 2013)
  • 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)
  • 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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