Duns Number:342751065
Device Description: IQM is quality assurance device for medical linear accelerators for verifying the treatmen IQM is quality assurance device for medical linear accelerators for verifying the treatment beam.
Catalog Number
-
Brand Name
IQM Integral Quality Monitor
Version/Model Number
1013 (vers 1.3)
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
K162629
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
e9d70b3f-ee77-4682-9399-078b0b79a78f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 03, 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. | 1 |