Duns Number:413819707
Device Description: Software medical device, used with a Philips Interventional X-Ray System. Extension of 3D- Software medical device, used with a Philips Interventional X-Ray System. Extension of 3D-RA. Provides live 3D image guidance for navigating endovascular devices through vascular structures.
Catalog Number
001004
Brand Name
MR-CT Roadmap
Version/Model Number
MR-CT Roadmap - 1
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
K121772
Product Code
JAK
Product Code Name
System, X-Ray, Tomography, Computed
Public Device Record Key
45d2880e-a061-4f88-892b-d871645ef68a
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 |