Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005383085

FEI Number

3005383085

Entity Name

PALODEX GROUP OY

City/State/Country

Tuusula Uusimaa, FI

Establishment Address

NAHKELANTIE 160, Tuusula Uusimaa 04300, FI

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

PaloDEx Group Oy (Owner Number: 9079085)

Owner / Operator Contact Address

Nahkelantie 160, --, TUUSULA, FI-18 04300, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200810

PMA Number

N/A

All Registered Proprietary Names

ORTHOPANTOMOGRAPH OP 3D DIGORA Optime DTX Studio Implant DTX Studio Clinic Imaging Plates for Imaging Plate Systems DTX Studio Assist DTX Studio Clinic Orthopantomograph OP 3D EX Orthopantomograph OP 3D LX IPS Casedesigner DTX Studio Clinic Orthopantomograph OP 3D EX Orthopantomograph OP 3D LX DTX Studio Core IPS Casedesigner

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	2018-06-29
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2014-04-07
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-03-23
MYN	Analyzer, Medical Image	Radiology	Class 2	892.2070	2026-03-09
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2026-03-09
IWZ	Film, Radiographic	Radiology	Class 1	892.1840	2022-03-23
MYN	Analyzer, Medical Image	Radiology	Class 2	892.2070	2026-03-09
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-03-09
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-03-23
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2023-06-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-03-23
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-03-23
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2024-09-18
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2019-06-07
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2016-09-06
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-03-23

Official Correspondent

No official correspondent registered.

US Agent Details

Erika Martin Business: DENTAL IMAGING TECHNOLOGIES CORPORATION Email: erika.martin@envistaco.com Phone: (980) 3094441

Related Public Records

Same Entity

PaloDEx Group 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
K221008	Shanghai Handy Medical Equipment Co., Ltd.	HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)	2022-06-22
K160788	Ray Co., Ltd.	RIOScan (RPS500)	2016-04-15
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005383085. Last updated year: 2026. Please use registration number 3005383085 when referencing this establishment in official correspondence.