Duns Number:785961244
Device Description: The Onrad™ Treatment System is a radiation therapy system that integrates planning, doseca The Onrad™ Treatment System is a radiation therapy system that integrates planning, dosecalculation, megavoltage CT imaging for IGRT functionality, and fixed beam (non-rotational)radiation therapy treatment capabilities into a single comprehensive system.The Onrad™ Treatment System is a prescription device. It delivers radiation in accordancewith a physician approved plan. The device does not diagnose disease, recommend treatmentregimens, or quantify treatment effectiveness. The megavoltage CT imaging functionality isnot intended for diagnostic use.
Catalog Number
NA
Brand Name
Onrad Treatment System
Version/Model Number
1049211
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K152488
Product Code
MUJ
Product Code Name
System, Planning, Radiation Therapy Treatment
Public Device Record Key
c8249a23-0cfe-4bd2-9aed-ddf436912f9b
Public Version Date
July 23, 2018
Public Version Number
1
DI Record Publish Date
June 22, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |