Duns Number:078466835
Catalog Number
-
Brand Name
Arterys Oncology DL
Version/Model Number
AOM4
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 01, 2019
Issuing Agency
In HIBCC
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
K173542
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
6deb5752-bafc-4d68-b1b2-34a950e9d1df
Public Version Date
June 25, 2020
Public Version Number
4
DI Record Publish Date
June 22, 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. | 7 |