Duns Number:413819707
Device Description: Software medical device, used with a Philips Interventional X-Ray System. Intended to prov Software medical device, used with a Philips Interventional X-Ray System. Intended to provide a real-time and dynamic angiographic roadmap of coronary arteries.
Catalog Number
001016
Brand Name
Dynamic Coronary Roadmap
Version/Model Number
Dynamic Coronary Roadmap - 2
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
K172307
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
2cadb534-c474-4149-8bfd-8d26be6a723c
Public Version Date
November 13, 2020
Public Version Number
7
DI Record Publish Date
November 07, 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. | 349 |