Duns Number:122240021
Device Description: Accessory to the 1177 MapCHECK2.
Catalog Number
1177000VZ
Brand Name
Varian IMF (Isocentric Mounting Fixture)
Version/Model Number
1177000VZ
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 21, 2019
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
K131466
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
57987fe8-5789-4d9e-a5d7-b5ca5160923f
Public Version Date
June 21, 2019
Public Version Number
5
DI Record Publish Date
January 14, 2017
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 | 26 |
2 | A medical device with a moderate to high risk that requires special controls. | 112 |