Duns Number:782779701
Device Description: IQQA-BodyImaging is an image analysis software for reviewing body imaging studies (includi IQQA-BodyImaging is an image analysis software for reviewing body imaging studies (including thoracic, abdominal and pelvic) derived from CT and MR scanners
Catalog Number
-
Brand Name
EDDA TECHNOLOGY
Version/Model Number
IQQA-BodyImaging
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
K141745
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
ab488688-1696-43eb-bce7-98718c022600
Public Version Date
October 07, 2019
Public Version Number
5
DI Record Publish Date
September 19, 2016
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. | 4 |