Duns Number:080444608
Device Description: ChartCheck assists in quality assessment of radiotherapy treatment plans and on treatment ChartCheck assists in quality assessment of radiotherapy treatment plans and on treatment chart review utilizing treatment, imaging, and documentation data in a simple, web-based interface.
Catalog Number
-
Brand Name
ChartCheck
Version/Model Number
1.2
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
K201119
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
233b26e3-2698-47bf-a0e6-a4d82dccd42e
Public Version Date
October 12, 2021
Public Version Number
1
DI Record Publish Date
October 04, 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 |