Duns Number:785961244
Device Description: Software, Version 1.1, iDMS™ Data Management SystemThe iDMS™ Data Management System is ind Software, Version 1.1, iDMS™ Data Management SystemThe 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
1057208
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
6650968a-b6e4-48fd-93c9-a20f80118a9b
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
August 28, 2017
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 |