Medical Device Manufacturer · FI , Helsinki

Planmed OY - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 1992
20
Total
20
Cleared
0
Denied

Planmed OY has 20 FDA 510(k) cleared radiology devices. Based in Helsinki, FI.

Latest FDA clearance: Sep 2025. Active since 1992.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.

FDA 510(k) Regulatory Record - Planmed OY
20 devices
1-20 of 20
Cleared Sep 26, 2025
Planmed XFI
K250318 · SFV
Radiology · 234d
Cleared Jul 18, 2022
Planmed Clarity 2D, Planmed Clarify S
K211720 · MUE
Radiology · 409d
Cleared Apr 28, 2022
Planmed Verity
K213278 · OAS
Radiology · 209d
Cleared Oct 23, 2020
Planmed Clarity 2D and Clarity S
K192317 · MUE
Radiology · 424d
Cleared Nov 30, 2018
Planmed Verity
K180918 · OAS
Radiology · 235d
Cleared Dec 28, 2017
Planmed Clarity
K163328 · MUE
Radiology · 395d
Cleared May 14, 2015
Planmed Verity
K143435 · OAS
Radiology · 164d
Cleared Feb 01, 2013
PLANMED VERITY
K121418 · JAK
Radiology · 266d
Cleared Nov 21, 2012
PLANMED NUANCE DIGIGUIDE
K121963 · MUE
Radiology · 139d
Cleared Nov 19, 2004
PLANMED SOPHIE NUANCE CLASSIC
K042671 · IZH
Radiology · 51d
Cleared Feb 21, 2003
PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)
K021945 · IZH
Radiology · 253d
Cleared Jan 16, 2002
PLANMED SOPHIE & PLANMED SOPHIE CLASSIC
K013656 · IZH
Radiology · 71d
Cleared Mar 15, 2001
PLANMED SOPHIE, PLANMED SOPHIE CLASSIC
K010116 · IZH
Radiology · 58d
Cleared Aug 10, 1999
PLANMED SOPHIE AND SOPHIE CLASSIC
K991826 · IZH
Radiology · 74d
Cleared Nov 16, 1998
PLANMED SOPHIE & PLANNED SOPHIE CLASSIC
K983659 · IZH
Radiology · 28d
Cleared Nov 10, 1997
PLANMED CYTOGUIDE
K973493 · IZH
Radiology · 56d
Cleared Feb 05, 1997
PLANNED SOPHIED CLASSIC
K962105 · IZH
Radiology · 250d
Cleared May 24, 1995
PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT
K951883 · IZH
Radiology · 51d
Cleared Apr 07, 1994
MOBILE SOPHIE MODIFICATION
K934373 · IZH
Radiology · 211d
Cleared Nov 24, 1992
PLANMED CYTOGUIDE
K923471 · IZH
Radiology · 133d
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