Duns Number:136977290
Device Description: A medical image software package that aids the physician in the diagnosis of patients by m A medical image software package that aids the physician in the diagnosis of patients by means of medical images. It is a DICOM viewer used to display, register and fuse medical images from multiple modalities for referring physicians.
Catalog Number
-
Brand Name
MIMviewer
Version/Model Number
3.9
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"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
56c032b5-7bf8-47b4-b9a0-5ba4dbf7dab7
Public Version Date
May 23, 2019
Public Version Number
2
DI Record Publish Date
April 22, 2019
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |