Duns Number:831659169
Device Description: The RefleXion Medical Radiotherapy System (RMRS), a hybrid imaging-therapy system, is capa The RefleXion Medical Radiotherapy System (RMRS), a hybrid imaging-therapy system, is capable ofdelivering intensity-modulated radiation therapy (IMRT), stereotactic body radiation therapy (SBRT),stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS) utilizing an on-board kilovoltage CT(kVCT) system for patient localization and field sizes based on jaws which are 40 cm wide, with slice widthchoices of 1.0 cm and 2.0 cm to optimize patient treatment. It is also equipped with a binary multileafcollimator (MLC) used to create intensity modulated radiation fields at a source-axis distance of 85 cm. Itcan achieve a nominal dose rate of 850 cGy/min.
Catalog Number
-
Brand Name
Reflexion Medical Radiotherapy System
Version/Model Number
RXM1000
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
K190978
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
dc61daaf-9d7b-4e9e-ab80-ce19f0c7ba0c
Public Version Date
March 02, 2021
Public Version Number
1
DI Record Publish Date
February 22, 2021
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |