Duns Number:080444608
Device Description: AutoContour is intended to assist radiation treatment planners in contouring and reviewing AutoContour is intended to assist radiation treatment planners in contouring and reviewing structures within medical images in preparation for radiation therapy treatment planning.
Catalog Number
-
Brand Name
AutoContour
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K200323
Product Code
QKB
Product Code Name
Radiological Image Processing Software For Radiation Therapy
Public Device Record Key
e2bfefe7-e66c-4d68-8061-b7df0f7e639b
Public Version Date
October 19, 2021
Public Version Number
1
DI Record Publish Date
October 11, 2021
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 |