Duns Number:073238441
Device Description: Odyssey is a Radiation Therapy Treatment Planning System, Windows based software system de Odyssey is a Radiation Therapy Treatment Planning System, Windows based software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be exported in DICOM formats to administer treatments after review and approval by the intended user.
Catalog Number
-
Brand Name
Odyssey
Version/Model Number
5.2.01
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
-
Product Code
MUJ
Product Code Name
System,Planning,Radiation Therapy Treatment
Public Device Record Key
5be71c63-c6f4-4509-ad48-cf16dcd78436
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 08, 2017
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. | 2 |