Planmed OY - FDA 510(k) Cleared Devices
20
Total
20
Cleared
0
Denied
FDA 510(k) cleared devices by Planmed OY Radiology ✕
20 devices
Cleared
Sep 26, 2025
Planmed XFI
Radiology
234d
Cleared
Jul 18, 2022
Planmed Clarity 2D, Planmed Clarify S
Radiology
409d
Cleared
Apr 28, 2022
Planmed Verity
Radiology
209d
Cleared
Oct 23, 2020
Planmed Clarity 2D and Clarity S
Radiology
424d
Cleared
Nov 30, 2018
Planmed Verity
Radiology
235d
Cleared
Dec 28, 2017
Planmed Clarity
Radiology
395d
Cleared
May 14, 2015
Planmed Verity
Radiology
164d
Cleared
Feb 01, 2013
PLANMED VERITY
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
Cleared
Mar 15, 2001
PLANMED SOPHIE, PLANMED SOPHIE CLASSIC
Radiology
58d
Cleared
Aug 10, 1999
PLANMED SOPHIE AND SOPHIE CLASSIC
Radiology
74d
Cleared
Nov 16, 1998
PLANMED SOPHIE & PLANNED SOPHIE CLASSIC
Radiology
28d
Cleared
Nov 10, 1997
PLANMED CYTOGUIDE
Radiology
56d
Cleared
Feb 05, 1997
PLANNED SOPHIED CLASSIC
Radiology
250d
Cleared
May 24, 1995
PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT
Radiology
51d
Cleared
Apr 07, 1994
MOBILE SOPHIE MODIFICATION
Radiology
211d
Cleared
Nov 24, 1992
PLANMED CYTOGUIDE
Radiology
133d