PLANMED SOPHIE NUANCE CLASSIC— 510(k) K042671

Substantially Equivalent

Planmed OY

FDA 510(k) clearance K042671 for PLANMED SOPHIE NUANCE CLASSIC, Substantially Equivalent on 2004-11-19. Applicant: Planmed OY. Device class: 2.

Clearance details

Applicant: Planmed OY
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 2004-09-29
Decision date: 2004-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roselle, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IZH

K203509 — SMART FINDER2021-07-14
K202294 — Affirm Contrast Biopsy2020-10-05
K191495 — Biopsy Positioner2019-07-03
K161575 — Affirm Lateral Arm Upright Biopsy Accessory2016-08-10
K161920 — Comfort Cover2016-07-15

More clearances from Planmed OY

K250318 — Planmed XFI2025-09-26
K211720 — Planmed Clarity 2D, Planmed Clarify S2022-07-18
K213278 — Planmed Verity2022-04-28
K192317 — Planmed Clarity 2D and Clarity S2020-10-23
K180918 — Planmed Verity2018-11-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.