Planmed OY
Medical device manufacturer in Helsinki, FI.
20510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K250318 | Planmed XFISFV · Traditional | 09/26/2025SE |
| K211720 | Planmed Clarity 2D, Planmed Clarify SMUE · Traditional | 07/18/2022SE |
| K213278 | Planmed VerityOAS · Traditional | 04/28/2022SE |
| K192317 | Planmed Clarity 2D and Clarity SMUE · Traditional | 10/23/2020SE |
| K180918 | Planmed VerityOAS · Traditional | 11/30/2018SE |
| K163328 | Planmed ClarityMUE · Traditional | 12/28/2017SE |
| K143435 | Planmed VerityOAS · Traditional | 05/14/2015SE |
| K121418 | Planmed VerityJAK · Traditional | 02/01/2013SE |
| K121963 | Planmed Nuance DigiguideMUE · Traditional | 11/21/2012SE |
| K042671 | Planmed Sophie Nuance ClassicIZH · Traditional | 11/19/2004SE |
| K021945 | Planmed Sophie & Sophie Classic (with Digispot and Cytoguide)IZH · Traditional | 02/21/2003SE |
| K013656 | Planmed Sophie & Planmed Sophie ClassicIZH · Traditional | 01/16/2002SE |
| K010116 | Planmed Sophie, Planmed Sophie ClassicIZH · Traditional | 03/15/2001SE |
| K991826 | Planmed Sophie and Sophie ClassicIZH · Traditional | 08/10/1999SE |
| K983659 | Planmed Sophie & Planned Sophie ClassicIZH · Abbreviated | 11/16/1998SE |
| K973493 | Planmed CytoguideIZH · Traditional | 11/10/1997SE |
| K962105 | Planned Sophied ClassicIZH · Traditional | 02/05/1997SE |
| K951883 | Planmed Sophie Mammographic X-Ray UnitIZH · Traditional | 05/24/1995SE |
| K934373 | Mobile Sophie ModificationIZH · Traditional | 04/07/1994SE |
| K923471 | Planmed CytoguideIZH · Traditional | 11/24/1992SE |