Duns Number:626962596
Device Description: ImagenPRO is a software application installed on desktop computers with allows physicians ImagenPRO is a software application installed on desktop computers with allows physicians and healthcare professionals to inspect, reconstruct, and reorient myocardial perfusion PET images. The system processes perfusion and gated PET raw emission and transmission data to create 3D tomographic data. The user can select correction parameters, filter setting, range of reconstruction, and reorientation angels.
Catalog Number
-
Brand Name
ImagenPRO
Version/Model Number
2.2
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K050366
Product Code
KPS
Product Code Name
System, Tomography, Computed, Emission
Public Device Record Key
ffe3ab4c-d0c0-4548-bc26-b5e6bb678b69
Public Version Date
October 07, 2019
Public Version Number
5
DI Record Publish Date
January 29, 2018
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. | 5 |