Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018064242

FEI Number

3018064242

Entity Name

DISIOR OY

City/State/Country

Helsinki Uusimaa, FI

Establishment Address

HTC Helsinki, Building Pinta, Tammasaarenkatu 3, Helsinki Uusimaa 00180, FI

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Disior Oy (Owner Number: 10077636)

Owner / Operator Contact Address

HTC Helsinki, Building Pinta, Tammasaarenkatu 3, Helsinki, FI-18 00180, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K203290

PMA Number

N/A

All Registered Proprietary Names

ENOS Software Guided External Fixation System SMART Bun-Yo-Matic Xray SMART Bun-Yo-Matic CT Bonelogic Bonelogic

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OSN	Software For Diagnosis/Treatment	Orthopedic	Class 2	888.3030	2026-04-01
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-07-10
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-07-10
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2023-12-15
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-02-09

Official Correspondent

Anna-Maria Henell

US Agent Details

Tina O'Brien Business: PARAGON28 Email: Tina.Obrien@zimmerbiomet.com Phone: (855) 7862828

Related Public Records

Same Entity

Disior 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
K242270	Orthofix Srl	OrthoNext Platform System	2024-12-19
K261713	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.6.0)	2026-06-18
K243647	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.5)	2025-06-30
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30

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)

Similar Registrations

Registration Number	Establishment Name	Location
3007366790	Smith & Nephew, Inc.	Memphis, TN, US
1220246	ARTHREX, INC.	Naples, FL, US
3025603301	STRAITS ORTHOPAEDICS (MFG) SDN BHD	Simpang Ampat Pulau Pinang, MY
1833986	PRECISION EDGE SURGICAL PRODUCTS COMPANY	Sault Sainte Marie, MI, US
3006460162	ORTHOPEDIATRICS, CORP	Warsaw, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018064242. Last updated year: 2026. Please use registration number 3018064242 when referencing this establishment in official correspondence.