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510(k) K122836

AFFIRM BREAST BIOPSY GUIDANCE SYSTEM by Lorad, A Hologic Co. — Product Code IZH

K122836 is an FDA 510(k) premarket notification submitted by Lorad, A Hologic Co. for the device "AFFIRM BREAST BIOPSY GUIDANCE SYSTEM". The FDA issued a decision of Substantially Equivalent on January 11, 2013. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Lorad, A Hologic Co. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2013
Date Received
September 17, 2012
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

Other clearances by Lorad, A Hologic Co.

  • K071542 — DIGITAL STEREOLOC II (July 5, 2007)
  • K030666 — MULTICARE PLATINUM SYSTEM AND ACCESSORIES (March 25, 2003)
  • K013290 — MODIFIED 650 MAMMOGRAPHY SYSTEM (October 24, 2001)
  • K011987 — MODIFIED M-IV MAMMOGRAPHY SYSTEM (July 11, 2001)

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)
  • K113607 — BIOPSY DIGIT S BIOPSY SL (August 10, 2012)
  • K113284 — BIOPSY POSITIONER (March 7, 2012)

FDA data resources