Medical Device Manufacturer · FI , Helsinki

Planmed OY - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 1992

Recent clearances: Planmed XFI, Planmed Clarity 2D, Planmed Clarify S, Planmed Verity

20

Total

20

Cleared

0

Denied

FDA 510(k) Regulatory Record - Planmed OY Radiology ✕

20 devices

1-12 of 20

Cleared Sep 26, 2025

Radiology · 234d

Cleared Jul 18, 2022

Planmed Clarity 2D, Planmed Clarify S

Radiology · 409d

Cleared Apr 28, 2022

Radiology · 209d

Cleared Oct 23, 2020

Planmed Clarity 2D and Clarity S

Radiology · 424d

Cleared Nov 30, 2018

Radiology · 235d

Cleared Dec 28, 2017

Planmed Clarity

Radiology · 395d

Cleared May 14, 2015

Radiology · 164d

Cleared Feb 01, 2013

Radiology · 266d

Cleared Nov 21, 2012

PLANMED NUANCE DIGIGUIDE

Radiology · 139d

Cleared Nov 19, 2004

PLANMED SOPHIE NUANCE CLASSIC

Radiology · 51d

Cleared Feb 21, 2003

PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)

Radiology · 253d

Cleared Jan 16, 2002

PLANMED SOPHIE & PLANMED SOPHIE CLASSIC

Radiology · 71d