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

Total

Cleared

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.

Planmed OY is one of 32 FDA 510(k) medical device manufacturers from Finland in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Planmed OY

20 devices

1-12 of 20

Planmed Clarity 2D, Planmed Clarify S

Planmed Clarity 2D and Clarity S

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

Planmed OY - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Planmed OY

Filters