VanDuzen, Inc. dba MedCAD

FDA Device Registration & Listing · Dallas, TX, US · Registration 3009196021

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009196021
FEI Number
3009196021
Entity Name
VanDuzen, Inc. dba MedCAD
City/State/Country
Dallas, TX, US
Establishment Address
501 S 2nd Ave Ste A1000, Dallas, TX 75226, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
MedCAD (Owner Number: 10037478)
Owner / Operator Contact Address
501 Second Ave., Suite A-1000, Dallas, TX 75226, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K251709
PMA Number
N/A

All Registered Proprietary Names

AccuModel AccuShape Titanium Patient-Specific Cranial Implant AccuShape AccuPlan System 3DTi MedCAD® AccuStride System AccuPlan System Orthopedics AccuPlate AccuPlate Patient-Specific Plate AccuPlate 3DTi Patient-Specific Plating System MedCAD® AccuStride System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWT Template Orthopedic Class 1 888.4800 2011-07-18
GXN Plate, Cranioplasty, Preformed, Non-Alterable Neurology Class 2 882.5330 2022-08-31
DZJ Driver, Wire, And Bone Drill, Manual Dental Class 2 872.4120 2021-07-20
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2021-07-20
GXN Plate, Cranioplasty, Preformed, Non-Alterable Neurology Class 2 882.5330 2011-07-18
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2023-09-21
DZJ Driver, Wire, And Bone Drill, Manual Dental Class 2 872.4120 2023-09-21
PBF Orthopaedic Surgical Planning And Instrument Guides Orthopedic Class 2 888.3030 2025-03-14
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2023-09-21
PBF Orthopaedic Surgical Planning And Instrument Guides Orthopedic Class 2 888.3030 2023-09-21
JEY Plate, Bone Dental Class 2 872.4760 2021-08-30
JEY Plate, Bone Dental Class 2 872.4760 2023-09-27
PBF Orthopaedic Surgical Planning And Instrument Guides Orthopedic Class 2 888.3030 2026-01-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-01-28

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MedCAD
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3021635140 MedCAD Plano, TX, US

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)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009196021. Last updated year: 2026. Please use registration number 3009196021 when referencing this establishment in official correspondence.
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