Duns Number:080044624
Device Description: Accuray Precision™ Treatment Planning System (Version 3.1)
Catalog Number
NA
Brand Name
Accuray Precision Treatment Planning System
Version/Model Number
1070891
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
K171086
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
df195cad-8987-4c64-a0f1-2b67b760a8e7
Public Version Date
June 28, 2021
Public Version Number
2
DI Record Publish Date
April 27, 2020
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. | 25 |