Duns Number:507639297
Device Description: The intended use of the device is• quality assurance of patient specific treatment deliver
Catalog Number
SDOS101-34
Brand Name
Delta4 Phantom+ MR
Version/Model Number
PW
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K183606
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
3aea9646-c7ec-46d2-a860-d4f2d300cf7c
Public Version Date
May 02, 2019
Public Version Number
1
DI Record Publish Date
April 24, 2019
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 |