ORPHEUS MEDICAL LTD

Address:Building #23, MATAM Industrial Park,HAIFA Northern,IL

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- Catalog Number : MVD-0001

Device Description : The Orpheus System is a picture archival and communications systems (PACS) that The Orpheus System is a picture archival and communications systems (PACS) that is intended for image capturing, archiving, displaying and recording of audio/video sequences and patient data during a procedure. The system allows for capture and annotation of the surgical procedure for documentation purposes and for viewing at a later time either locally or on a secure distributed network. The captured audio/video sequences can be broadcasted in real time with video-conferencing capability during the broadcast. The Orpheus System is not intended to be used as a primary diagnostic system for mammography and any other radiology application.

Device Class : 2

Duns Number: 533221750

Premarket Exempt : Yes

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : MCU-EG00401

Device Description : Application for sending a live video stream from the medical operating theater t Application for sending a live video stream from the medical operating theater to remote viewers.The class of HW devices with or without a touch panel display (TPD). It is used to connect to a video source and capture, archive and stream the video to the Orpheus System central server and over the multi-cast network to be viewed from the Orpheus Show application.

Device Class : 2

Duns Number: 533221750

Premarket Exempt : Yes

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Device Description : Application for sending a live video stream from the medical operating theater t Application for sending a live video stream from the medical operating theater to remote viewers.The class of HW devices with or without a touch panel display (TPD). It is used to connect to a video source and capture, archive and stream the video to the Orpheus System central server and over the multi-cast network to be viewed from the Orpheus Show application.

Device Class : 2

Duns Number: 533221750

Premarket Exempt : Yes

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : MCU-EG00407

Device Description : Application for sending a live video stream from the medical operating theater t Application for sending a live video stream from the medical operating theater to remote viewers.The class of HW devices with or without a touch panel display (TPD). It is used to connect to a video source and capture, archive and stream the video to the Orpheus System central server and over the multi-cast network to be viewed from the Orpheus Show application.

Device Class : 2

Duns Number: 533221750

Premarket Exempt : Yes

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Device Class : 2

Duns Number: 533221750

Premarket Exempt : Yes

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : MVU-EG00D01

Device Description : Multi viewer video switch

Device Class : 2

Duns Number: 533221750

Premarket Exempt : Yes

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : MPU-EG00C01

Device Description : A "2 part" medical Foot Pedal connected to the Orpheus CAST to operate: start/s A "2 part" medical Foot Pedal connected to the Orpheus CAST to operate: start/stop, snapshot taking.

Device Class : 2

Duns Number: 533221750

Premarket Exempt : Yes

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : MCU-EG00405

Device Class : 2

Duns Number: 533221750

Premarket Exempt : Yes

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : MAU-EG20001

Device Class : 2

Duns Number: 533221750

Premarket Exempt : Yes

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : MAU-EG20004

Device Description : A Windows based desktop widget application that can be connected to the laptop’s 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.

Device Class : 2

Duns Number: 533221750

Premarket Exempt : Yes

Product Code : LLZ

Prescription Use : Yes

Device Count : 1