Duns Number:537689275
Device Description: The Prelude software supports intra-operative radiation therapy workflows with intra-opera The Prelude software supports intra-operative radiation therapy workflows with intra-operative radiation devices like IntraOp Mobetron.It assists to find product specific machine parameters for treatment and can send those proposals to the intra-operative radiation device.The machine parameters are not intended to be used for direct control for the radiation device.Machine Output Quality can be visualized and recorded over time for quality assurance.
Catalog Number
-
Brand Name
Prelude
Version/Model Number
V1.
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
K180308
Product Code
LHO
Product Code Name
Instrument, Quality-Assurance, Radiologic
Public Device Record Key
c454c0c6-b6e6-4956-bcdc-9016bf97c3f5
Public Version Date
June 10, 2020
Public Version Number
1
DI Record Publish Date
June 02, 2020
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |