Duns Number:533221750
Device Description: A native iOS and Android mobile application also compatible with iPad. It is used to:• Loc A native iOS and Android mobile application also compatible with iPad. It is used to:• Locate patients according to patient ID• Locate scheduled procedures by connecting to modality worklist• Capture videos, images and audio files to be included in the study case.• Add notes and tags to each file (asset).• Upload any file to the Orpheus System• Manually or automatically delete files from the file library
Catalog Number
ML-EG30001
Brand Name
Orpheus CAST Mobile App Android OS
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
d12d5be8-9456-402f-ac48-f2b87825028d
Public Version Date
April 22, 2020
Public Version Number
1
DI Record Publish Date
April 14, 2020
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 |