Orpheus CAST Mobile App iOS + Android

Basic Information

• Brand Name: Orpheus CAST Mobile App iOS + Android
• Primary DI: 07290017025100
• Version / Model: 01
• Catalog Number: MLL-EG30001
• Company Name: ORPHEUS MEDICAL LTD
• Labeler DUNS: 533221750
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-03
• Public Version: 1
• Public Version Date: 2019-09-11
• Public Version Status: New
• Public Device Record Key: f8752654-74e2-49e0-b804-b6c61fcc6bb5

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44087	Radiology information system application software	An application software program, routines, and/or algorithms used as or in a radiology information system (RIS) to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within/between facilites, to support the administrative and clinical activities associated with the provision and utilization of radiology services and facilities. It may be used for patient scheduling and work-list generation for specific radiological systems; it may be used in conjunction with PACS and include various technology imaging modalities. It is installed into a dedicated radiology information system or existing mainframe or decentralized computers/network.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290017025100	GS1