Duns Number:413819707
Device Description: Software medical device used with a Philips Interventional X-Ray System. Provides color co Software medical device used with a Philips Interventional X-Ray System. Provides color coded representation of digital subtraction angiography to assist diagnosis of perfusion alterations of tissues.
Catalog Number
001119
Brand Name
SmartPerfusion
Version/Model Number
SmartPerfusion - 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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K181966
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
f97b8a45-dab0-4bc8-8e5c-60bfc52417ab
Public Version Date
November 13, 2020
Public Version Number
5
DI Record Publish Date
November 19, 2018
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 |