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510(k) K113607

BIOPSY DIGIT S BIOPSY SL by Giotto USA, LLC — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2012
Date Received
December 6, 2011
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

Other clearances by Giotto USA, LLC

  • K111434 — GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L (October 27, 2011)
  • K062039 — BIOPSY DIGIT-AM (September 11, 2006)

Other clearances for product code IZH

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  • K202294 — Affirm Contrast Biopsy (October 5, 2020)
  • K191495 — Biopsy Positioner (July 3, 2019)
  • K161575 — Affirm Lateral Arm Upright Biopsy Accessory (August 10, 2016)
  • K161920 — Comfort Cover (July 15, 2016)
  • K153486 — Affirm Prone Biopsy System (April 1, 2016)
  • K152038 — MammoGRIP (December 22, 2015)
  • K122836 — AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (January 11, 2013)
  • K123414 — SPECBOARD JR. (January 11, 2013)
  • K113284 — BIOPSY POSITIONER (March 7, 2012)