EzMobile

GUDID 08800019700142

EzMobile is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. EzMobile is intended for use as software to acquire, view and save 2D image files, load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.

EWOO SOFT Co., Ltd

General-purpose dental x-ray system application software
Primary Device ID08800019700142
NIH Device Record Keyafcb7572-4f06-4180-90a4-5f895b074869
Commercial Distribution StatusIn Commercial Distribution
Brand NameEzMobile
Version Model Numberv1.1
Company DUNS688379797
Company NameEWOO SOFT Co., Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800019700142 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-13
Device Publish Date2020-02-05

Devices Manufactured by EWOO SOFT Co., Ltd

08800019700531 - EzDent-i2024-08-21 EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These t
08800019700401 - Ez3D-i2023-08-03 Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These too
08800019700395 - EzDent Web2023-07-24 EzDent Web is a dental imaging software that enables you to save, manage, view and process patients’ images. EzDent Web is equ
08800019700388 - EzDent-i2023-03-15 EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These t
08800019700319 - EzOrtho2022-10-21 EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogra
08800019700340 - Ez3D-i2022-10-21 Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These too
08800019700357 - EzDent-i2022-10-21 EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These t
08800019700227 - EzDent-i2021-11-16 EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These t

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