Duns Number:339852325
Device Description: The NOVAC 11 is an electron linear accelerator used for radiation therapy duringsurgical p The NOVAC 11 is an electron linear accelerator used for radiation therapy duringsurgical procedures in an operating room for the treatment of malignant and benignconditions. Known as Intraoperative Radiation Therapy (IORT), this technique allowsdelivery of high doses of radiation directly aimed at tumors or other sites while avoidingdosage to surgically mobilized normal tissues.The NOVAC 11 is a mobile and articulated machine that can be moved towards thepatient and put in the appropriate position to carry out the necessary radiotherapy.
Catalog Number
N300000-01-03
Brand Name
NOVAC11
Version/Model Number
10 MeV
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
K112286
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
a15f6a58-465c-4fdb-b1da-64dd0ab00ea0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 12, 2016
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. | 9 |