Duns Number:103977526
Device Description: For securing the Varian IsoCal phantom to the CIVCO 53cm UCT Couchtop
Catalog Number
MTIL6152
Brand Name
MPC IsoCal Phantom Mount Assembly
Version/Model Number
MTIL6152
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
K973842
Product Code
IXQ
Product Code Name
Table, radiographic, stationary top
Public Device Record Key
19b193bc-bbdb-4bbf-8aca-0f673f9502af
Public Version Date
May 31, 2019
Public Version Number
3
DI Record Publish Date
April 13, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 31 |
2 | A medical device with a moderate to high risk that requires special controls. | 1027 |