Duns Number:808875397
Device Description: Encompass SRS MRI Standalone Device with E0 headrest & hand grip array
Catalog Number
RT-4600-01-MRI
Brand Name
Encompass™
Version/Model Number
RT-4600-01-MRI
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K152321
Product Code
IYE
Product Code Name
Accelerator, linear, medical
Public Device Record Key
56621795-c1be-4dc3-89e4-74b6fb7cb551
Public Version Date
March 11, 2019
Public Version Number
4
DI Record Publish Date
September 14, 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 | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 998 |