Medical Device Manufacturer · FI , Helsinki

Planmed OY

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

Planmed OY — FDA 510(k) Submissions

Planmed OY has submitted 20 FDA 510(k) premarket notifications since 1992, of which 20 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, X-ray, Mammographic, Full Field Digital, System, X-ray, Mammographic, X-ray, Tomography, Computed, Dental, System, X-ray, Tomography, Computed, X-ray, Computed Tomography, Cone-beam . Use the specialty filter in the sidebar to narrow results.

20 devices
1–20 of 20
Planmed XFI
K250318 · SFV X-ray, Computed... · Radiology
Sep 2025 234d
Planmed Clarity 2D, Planmed Clarify S
K211720 · MUE Full Field Digital,... · Radiology
Jul 2022 409d
Planmed Verity
K213278 · OAS X-ray, Tomography,... · Radiology
Apr 2022 209d
Planmed Clarity 2D and Clarity S
K192317 · MUE Full Field Digital,... · Radiology
Oct 2020 424d
Planmed Verity
K180918 · OAS X-ray, Tomography,... · Radiology
Nov 2018 235d
Planmed Clarity
K163328 · MUE Full Field Digital,... · Radiology
Dec 2017 395d
Planmed Verity
K143435 · OAS X-ray, Tomography,... · Radiology
May 2015 164d
PLANMED VERITY
K121418 · JAK System, X-ray,... · Radiology
Feb 2013 266d
PLANMED NUANCE DIGIGUIDE
K121963 · MUE Full Field Digital,... · Radiology
Nov 2012 139d
PLANMED SOPHIE NUANCE CLASSIC
K042671 · IZH System, X-ray, Mammographic · Radiology
Nov 2004 51d
PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)
K021945 · IZH System, X-ray, Mammographic · Radiology
Feb 2003 253d
PLANMED SOPHIE & PLANMED SOPHIE CLASSIC
K013656 · IZH System, X-ray, Mammographic · Radiology
Jan 2002 71d
PLANMED SOPHIE, PLANMED SOPHIE CLASSIC
K010116 · IZH System, X-ray, Mammographic · Radiology
Mar 2001 58d
PLANMED SOPHIE AND SOPHIE CLASSIC
K991826 · IZH System, X-ray, Mammographic · Radiology
Aug 1999 74d
PLANMED SOPHIE & PLANNED SOPHIE CLASSIC
K983659 · IZH System, X-ray, Mammographic · Radiology
Nov 1998 28d
PLANMED CYTOGUIDE
K973493 · IZH System, X-ray, Mammographic · Radiology
Nov 1997 56d
PLANNED SOPHIED CLASSIC
K962105 · IZH System, X-ray, Mammographic · Radiology
Feb 1997 250d
PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT
K951883 · IZH System, X-ray, Mammographic · Radiology
May 1995 51d
MOBILE SOPHIE MODIFICATION
K934373 · IZH System, X-ray, Mammographic · Radiology
Apr 1994 211d
PLANMED CYTOGUIDE
K923471 · IZH System, X-ray, Mammographic · Radiology
Nov 1992 133d
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