Duns Number:537689275
Device Description: The Prelude software supports radiation therapy workflows for IntraOp Mobetron, a radiatio The Prelude software supports radiation therapy workflows for IntraOp Mobetron, a radiation treatment device.It assists to find product specific machine parameters for treatment and can send those proposals to the console of the device.The machine parameters are not intended to be used for direct control for the radiation device.
Catalog Number
-
Brand Name
Prelude
Version/Model Number
V1. IORT
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,K180308
Product Code
LHO
Product Code Name
Instrument, Quality-Assurance, Radiologic
Public Device Record Key
38453097-0d00-435d-9e0b-c0c14d42e5e3
Public Version Date
October 13, 2022
Public Version Number
1
DI Record Publish Date
October 05, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |