Duns Number:079168716
Device Description: The MOBETRON is intended for use as an Electron Beam source inside an Operating Room for E The MOBETRON is intended for use as an Electron Beam source inside an Operating Room for Electron Beam IORT. Electron beam IORT (Intra-Operative Radiation Therapy) is the use of electron radiation during surgery to treat both malignant and benign tumors. The Mobetron is not intended for unrestricted beam production. Extensive beam testing should be done in a stray radiation shielded room or a strictly controlled area. MOBETRON S/N: 72
Catalog Number
-
Brand Name
MOBETRON
Version/Model Number
MOBETRON
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K981112
Product Code
LHN
Product Code Name
System, Radiation Therapy, Charged-Particle, Medical
Public Device Record Key
1df06bae-11c0-4e03-9d67-407e0fdf14a1
Public Version Date
July 16, 2018
Public Version Number
1
DI Record Publish Date
June 15, 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. | 1 |