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510(k) K121109

AERODR X70 by Konica Minolta Medical & Graphic, Inc. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2012
Date Received
April 12, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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.

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  • K123499 — AEROPILOT (December 20, 2012)
  • K120752 — AERODR STITCHING SYSTEM (June 8, 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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