Duns Number:413819707
Device Description: Software medical device, used with a Philips Interventional X-Ray System. Creates a 3D mod Software medical device, used with a Philips Interventional X-Ray System. Creates a 3D model of the coronary vessel tree from a pair of 2D images from a rotational angiographic run.
Catalog Number
001009
Brand Name
Allura 3D-CA
Version/Model Number
Allura 3D-CA - 3
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
K042334
Product Code
IZI
Product Code Name
System, X-Ray, Angiographic
Public Device Record Key
d608ca57-210f-4e14-9a15-242abfd2f281
Public Version Date
November 13, 2020
Public Version Number
7
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 |