Duns Number:413819707
Device Description: The IntelliSpace Portal IX V6.5 processes clinical images from a SBI* series that was gene The IntelliSpace Portal IX V6.5 processes clinical images from a SBI* series that was generated by Philips IQon system and enables advanced visualization of the images. When used by qualified personnel, it provides useful diagnostic information. IntelliSpace Portal IX V6.5 can be used remotely by multiple users with compatible devices *SBI: Spectral Base Images. A set of dataset that are being used as the inputs for calculation of Spectral results that are being used for reading.
Catalog Number
-
Brand Name
IntelliSpace Portal IX
Version/Model Number
6.5
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K150665
Product Code
LLZ
Product Code Name
System, image processing, radiological
Public Device Record Key
cc266351-9e05-49b0-b786-9befe72f4b57
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
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. | 349 |