Duns Number:688379797
Device Description: Smart M Viewer(EzDent-i OEM) is medical imaging software that is intended to provide diagn 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.
Catalog Number
-
Brand Name
Smart M Viewer
Version/Model Number
v3.0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K190087
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
f059a845-2877-495a-96db-a6032ce5227b
Public Version Date
May 15, 2020
Public Version Number
1
DI Record Publish Date
May 07, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |