Duns Number:507639297
Device Description: The intended use of the device is• quality assurance of patient specific treatment deliver The intended use of the device is• quality assurance of patient specific treatment delivery during and before external radiotherapy treatment, including IMRT, VMAT and 4DRT (respiratory gating and tumour tracking)• quality assurance of the radiation delivery system.
Catalog Number
SDOS105-01 (Varian)
Brand Name
Delta4 Discover
Version/Model Number
SDOS105-01
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K151426
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
181a180f-c239-47fe-9373-08257cd53a80
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 25, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |