Duns Number:785961244
Device Description: The TomoTherapy Treatment Delivery System with iDMS is indicated for the delivery of radia The TomoTherapy Treatment Delivery System with iDMS is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.
Catalog Number
NA
Brand Name
TomoTherapy Treatment Delivery System with iDMS
Version/Model Number
1068286
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
K171837
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
7ffec45f-3732-4a37-8e25-5e4303e57275
Public Version Date
December 03, 2018
Public Version Number
1
DI Record Publish Date
November 02, 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. | 38 |