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510(k) K923471

PLANMED CYTOGUIDE by Planmed OY — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1992
Date Received
July 14, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1710
Review Panel
RA
Submission Type

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  • K042671 — PLANMED SOPHIE NUANCE CLASSIC (November 19, 2004)

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  • K123414 — SPECBOARD JR. (January 11, 2013)
  • K122836 — AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (January 11, 2013)
  • K113607 — BIOPSY DIGIT S BIOPSY SL (August 10, 2012)