Duns Number:413819707
Device Description: Software medical device, used with a Philips Interventional X-Ray System. Provides high re Software medical device, used with a Philips Interventional X-Ray System. Provides high resolution visualization of stents in vessels. Supports the user in placing and deploying stents.
Catalog Number
001007
Brand Name
StentBoost
Version/Model Number
StentBoost - 4
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
K132305
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
75cf20f0-4683-4684-b4e9-917154fc5597
Public Version Date
November 13, 2020
Public Version Number
9
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 |