Chrysalis Intelligence · Sponsors · Planmed OY

Planmed OY

Helsinki, FI · 4 510(k) clearances

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Total clearances

4

2020-10-23 → 2025-09-26

Last 12 months

1

Product codes

3

Most recent

2025-09-26

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
MUE	Full Field Digital, System, X-Ray, Mammographic	Class II	Radiology	2	2022-07-18
SFV	X-Ray, Computed Tomography, Cone-Beam	Class II	Radiology	1	2025-09-26
OAS	X-Ray, Tomography, Computed, Dental	Class II	Radiology	1	2022-04-28

Filings

All 510(k) clearances (4)

Date	K-number	Device	Code	Class	Specialty
2025-09-26	K250318	Planmed XFI	SFV	Class II	Radiology
2022-07-18	K211720	Planmed Clarity 2D, Planmed Clarify S	MUE	Class II	Radiology
2022-04-28	K213278	Planmed Verity	OAS	Class II	Radiology
2020-10-23	K192317	Planmed Clarity 2D and Clarity S	MUE	Class II	Radiology