Duns Number:785961244
Device Description: Software, Version 2.0, Accuray Precision Treatment Planning SystemThe Accuray Precision Tr Software, Version 2.0, Accuray Precision Treatment Planning SystemThe Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.
Catalog Number
NA
Brand Name
Accuray Precision® Treatment Planning System
Version/Model Number
1064270
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K171086
Product Code
MUJ
Product Code Name
System, Planning, Radiation Therapy Treatment
Public Device Record Key
6dc016b0-1ee3-4fdf-a286-42bd582d6319
Public Version Date
October 25, 2018
Public Version Number
1
DI Record Publish Date
September 24, 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. | 38 |