Duns Number:533221750
Device Description: A Windows based desktop widget application that can be connected to the laptop’s webcam, t A Windows based desktop widget application that can be connected to the laptop’s webcam, the Orpheus GATE or a USB connected camera.It is useful also to drag images from a USB connected camera/smartphone or from the PC/Laptop directory and upload to the Orpheus System.For example: discharge workflow in which clinicians record a video session with the patient explaining their care path and requirements after discharge.
Catalog Number
MAU-EG20004
Brand Name
Orpheus CAST App
Version/Model Number
01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
96a2060e-192a-41b5-8194-cbd6736698ea
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 05, 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. | 13 |