Duns Number:785961244
Device Description: Software, iDMS™ Data Management System, (Version 1.1.1.1)The iDMS™ Data Management System Software, iDMS™ Data Management System, (Version 1.1.1.1)The iDMS™ Data Management System is indicated for the storage, retrieval, and processing of data utilized in the practice of radiotherapy, stereotactic radiotherapy and stereotactic radiosurgery.
Catalog Number
NA
Brand Name
iDMS™ Data Management System
Version/Model Number
1062409
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
K161144
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
5ae6dff0-8d51-4c87-8980-8743a6630933
Public Version Date
December 24, 2018
Public Version Number
1
DI Record Publish Date
November 23, 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 |