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510(k) K113607

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

K113607 is an FDA 510(k) premarket notification submitted by Giotto USA, LLC for the device "BIOPSY DIGIT S BIOPSY SL". The FDA issued a decision of Substantially Equivalent on August 10, 2012. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Giotto USA, LLC has at least 2 other 510(k) clearances on record.

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

  • K203509 — SMART FINDER (July 14, 2021)
  • 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)
  • K123414 — SPECBOARD JR. (January 11, 2013)
  • K122836 — AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (January 11, 2013)
  • K113284 — BIOPSY POSITIONER (March 7, 2012)

FDA data resources