Duns Number:626962596
Device Description: ImagenUniversal is a Windows application that allows physicians and healthcare professiona ImagenUniversal is a Windows application that allows physicians and healthcare professionals to correct myocardial perfusion PET images for transmission and emission misregistration, prompt gamma events, photon scatter and image noise.
Catalog Number
-
Brand Name
ImagenUniversal
Version/Model Number
2.0
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K173547
Product Code
KPS
Product Code Name
System, Tomography, Computed, Emission
Public Device Record Key
4173b7c5-5c10-48ee-8f1a-fadce92b2292
Public Version Date
October 07, 2019
Public Version Number
5
DI Record Publish Date
January 31, 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 |