Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012075008

FEI Number

3012075008

Entity Name

Synaptive Medical Inc

City/State/Country

Mississauga Ontario, CA

Establishment Address

5055 Satellite Drive, Unit #1, Mississauga Ontario L4W 5K7, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Synaptive Medical Inc (Owner Number: 10046804)

Owner / Operator Contact Address

5055 Satellite Drive, Unit #1, Mississauga, CA-ON L4W 5K7, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ImageDrive Clinical BrightMatter Navigation System Modus Plan Modus Nav 55 Sony Display Evry SYNQ Synaptive MRI BrightMatter Planning Software BrightMatter Guide Trackable Suction

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-07-04
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2015-04-02
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-03-16
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2019-10-04
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2016-08-22
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2020-04-30
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2014-06-10
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2016-07-04
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2016-10-21

Official Correspondent

Michael McDonald

US Agent Details

Elaine Duncan Business: Paladin Medical Inc Email: duncan@paladinmedical.com Phone: (715) 5496035

Related Public Records

Same Entity

Synaptive Medical Inc

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
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
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

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
3017991646	CARDIOWISE, INC.	Fayetteville, AR, US
3007120336	GE Healthcare Magyarorszag Kft.	Budapest, HU
3036758981	TAEYOUNG SOFT	Gwacheon-si Gyeonggi, KR
3010956703	Visual Medica	Ciudad Autonoma Buenos Aires Buenos Aires, Ciudad Autonoma de, AR
3030088963	REBRAIN	PESSAC Gironde, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012075008. Last updated year: 2026. Please use registration number 3012075008 when referencing this establishment in official correspondence.