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510(k) K010116

PLANMED SOPHIE, PLANMED SOPHIE CLASSIC by Planmed OY — Product Code IZH

K010116 is an FDA 510(k) premarket notification submitted by Planmed OY for the device "PLANMED SOPHIE, PLANMED SOPHIE CLASSIC". The FDA issued a decision of Substantially Equivalent on March 15, 2001. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Planmed OY has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2001
Date Received
January 16, 2001
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 Planmed OY

  • K250318 — Planmed XFI (September 26, 2025)
  • K211720 — Planmed Clarity 2D, Planmed Clarify S (July 18, 2022)
  • K213278 — Planmed Verity (April 28, 2022)
  • K192317 — Planmed Clarity 2D and Clarity S (October 23, 2020)
  • K180918 — Planmed Verity (November 30, 2018)
  • K163328 — Planmed Clarity (December 28, 2017)
  • K143435 — Planmed Verity (May 14, 2015)
  • K121418 — PLANMED VERITY (February 1, 2013)
  • K121963 — PLANMED NUANCE DIGIGUIDE (November 21, 2012)
  • K042671 — PLANMED SOPHIE NUANCE CLASSIC (November 19, 2004)

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)
  • K113607 — BIOPSY DIGIT S BIOPSY SL (August 10, 2012)

FDA data resources