Home / 510(k) Clearances / K203509

510(k) K203509

SMART FINDER by Ims Giotto S.P.A. — Product Code IZH

K203509 is an FDA 510(k) premarket notification submitted by Ims Giotto S.P.A. for the device "SMART FINDER". The FDA issued a decision of Substantially Equivalent on July 14, 2021. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Ims Giotto S.P.A. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2021
Date Received
November 30, 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

Other clearances by Ims Giotto S.P.A.

  • K200424 — Giotto Class (Models - 3000X-YY and 4000X-YY) (June 18, 2020)

Other clearances for product code IZH

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

FDA data resources