Duns Number:136977290
Device Description: A medical imaging software package that provide imaging solutions in the fields of radiati A medical imaging software package that provide imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging and cardiac imaging.
Catalog Number
-
Brand Name
MIM
Version/Model Number
7.0
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"
-
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
6702da89-501d-495e-a7de-7de31c7f3d1d
Public Version Date
October 18, 2019
Public Version Number
1
DI Record Publish Date
October 10, 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 |