ORPHEUS MEDICAL LTD

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

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Image Processing, Radiological (LLZ) (3)

Premarket Exempt

Yes

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Orpheus CAST Mobile App iOS + Android - 07290017025100 Catalog Number : MLL-EG30001

Device Description : A native iOS and Android mobile application also compatible with iPad. It is use 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 Class : 2

Duns Number: 533221750

Premarket Exempt : Yes

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Orpheus VOD CSS - 07290017025117 Catalog Number : MSU-EG30001

Device Description : 3rd party rack external server

Device Class : 2

Duns Number: 533221750

Premarket Exempt : Yes

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Orpheus CAST Mobile App Android OS - 07290017025124 Catalog Number : ML-EG30001

Device Class : 2

Duns Number: 533221750

Premarket Exempt : Yes

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

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