Smart M Viewer

GUDID 08800019700180

Smart M Viewer(EzDent-i OEM) is medical 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. Smart M Viewer (EzDent-i OEM) is intended for use as software to acquire, view, save 2D image files, and 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 ID: 08800019700180
• NIH Device Record Key: f059a845-2877-495a-96db-a6032ce5227b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smart M Viewer
• Version Model Number: v3.0
• Company DUNS: 688379797
• Company Name: EWOO SOFT Co., Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800019700180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190087

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-15
• Device Publish Date: 2020-05-07

Devices Manufactured by EWOO SOFT Co., Ltd

• 08800019700531 - EzDent-i: 2024-08-21 EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These t
• 08800019700401 - Ez3D-i: 2023-08-03 Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These too
• 08800019700395 - EzDent Web: 2023-07-24 EzDent Web is a dental imaging software that enables you to save, manage, view and process patients’ images. EzDent Web is equ
• 08800019700388 - EzDent-i: 2023-03-15 EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These t
• 08800019700319 - EzOrtho: 2022-10-21 EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogra
• 08800019700340 - Ez3D-i: 2022-10-21 Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These too
• 08800019700357 - EzDent-i: 2022-10-21 EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These t
• 08800019700227 - EzDent-i: 2021-11-16 EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These t