Duns Number:860393884
Device Description: The qER-Quant device is intended for automatic labeling, visualization and quantification The qER-Quant device is intended for automatic labeling, visualization and quantification of segmentable brain structures from a set of Non-Contrast head CT (NCCT) images. The software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on NCCT images.
Catalog Number
-
Brand Name
qER-Quant
Version/Model Number
1.0.0
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
K211222
Product Code
QIH
Product Code Name
Automated Radiological Image Processing Software
Public Device Record Key
52aeba6c-5c3e-4371-8882-d09b5685f23e
Public Version Date
June 08, 2022
Public Version Number
1
DI Record Publish Date
May 31, 2022
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. | 3 |