Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043728

FEI Number

3002807903

Entity Name

Planmed Oy

City/State/Country

Helsinki Uusimaa, FI

Establishment Address

Sorvaajankatu 7, Helsinki Uusimaa 00880, FI

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Planmed Oy (Owner Number: 10023610)

Owner / Operator Contact Address

Asentajankatu 6, Helsinki, FI-18 00880, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211720

PMA Number

N/A

All Registered Proprietary Names

Planmed Verity Planmed XFI Planmed Clarity 2D Planmed Clarity S

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2022-08-16
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2022-08-16
SFV	X-Ray, Computed Tomography, Cone-Beam	Radiology	Class 2	892.1750	2025-11-20
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2022-08-16

Official Correspondent

Niina Vuorikallas

US Agent Details

Brett Hetherington Business: Planmeca U.S.A. Inc. Email: Brett.Hetherington@planmecausa.com Phone: (612) 8685872

Related Public Records

Same Entity

Planmed Oy

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243523	Siemens Medical Solutions USA, Inc.	NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime	2025-02-12
K781431	General Electric Co.	ELECTRIC CT/T OPERATOR DISPLAY CONSOLE	1978-09-07
K231574	FUJIFILM Healthcare Americas Corporation	Scenaria View 4.2	2023-10-12
K233583	FUJIFILM Healthcare Americas Corporation	FCT iSTREAM Phase 1	2024-04-26
K151376	Covidien, LLC	superDimension Navigation System	2015-11-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2011	GE Medical Systems, LLC	2	HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017	Philips Medical Systems	2	Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017	Philips Medical Systems	2	Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0011-2017	Philips Medical Systems	2	Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0012-2017	Philips Medical Systems	2	Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Similar Registrations

Registration Number	Establishment Name	Location
3010281549	J. MORITA MFG. CORP., TOTTORI FACTORY	Kurayoshi Tottori, JP
9615832	OWANDY RADIOLOGY	CROISSY-BEAUBOURG Seine-et-Marne, FR
3004706313	VATECH CO., LTD.	Hwaseong-si Gyeonggi, KR
3005383085	PALODEX GROUP OY	Tuusula Uusimaa, FI
3005843418	GENORAY CO., LTD.	Seongnam-si Gyeonggi, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043728. Last updated year: 2026. Please use registration number 8043728 when referencing this establishment in official correspondence.