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510(k) K202294

Affirm Contrast Biopsy by Hologic, Inc. — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2020
Date Received
August 13, 2020
Clearance Type
Special
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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Other clearances for product code IZH

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  • K191495 — Biopsy Positioner (July 3, 2019)
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  • K152038 — MammoGRIP (December 22, 2015)
  • K122836 — AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (January 11, 2013)
  • K123414 — SPECBOARD JR. (January 11, 2013)
  • K113607 — BIOPSY DIGIT S BIOPSY SL (August 10, 2012)
  • K113284 — BIOPSY POSITIONER (March 7, 2012)