Duns Number:626962596
Device Description: The ImagenMD with ImagenQ system is software that allows the user to visualize raw PET and The ImagenMD with ImagenQ system is software that allows the user to visualize raw PET and/or PET/CT data, assist in evaluating the quality of PET scans, and perform quantitative measurements of tracer uptake to aid in the interpretation of myocardial perfusion PET images.
Catalog Number
-
Brand Name
ImagenQ
Version/Model Number
V2.0
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
K080770
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
856bae61-5c1a-4745-a4b4-454e2b1a7c56
Public Version Date
October 07, 2019
Public Version Number
5
DI Record Publish Date
February 21, 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 |