Duns Number:539852079
Device Description: MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation therapy planning purposes. MR-RT consists of RTGo SW and MR CouchTop accessory. RTgo is a softwar
Catalog Number
300005806302
Brand Name
MR-RT
Version/Model Number
RTgo 5.0 5
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
K214081
Product Code
MUJ
Product Code Name
System, planning, radiation therapy treatment
Public Device Record Key
bce14942-3a04-4d2d-9eb4-2bcd24f1c73d
Public Version Date
June 22, 2022
Public Version Number
1
DI Record Publish Date
June 14, 2022
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 |