| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 07290017025124 | 01 | ML-EG30001 | 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 | LLZ | System, Image Processing, Radiological | 2 | Orpheus CAST Mobile App Android OS |
| 2 | 07290017025094 | 01 | MAU-EG20004 | 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. | LLZ | System, Image Processing, Radiological | 2 | Orpheus CAST App |
| 3 | 07290017025100 | 01 | MLL-EG30001 | 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 | LLZ | System, Image Processing, Radiological | 2 | Orpheus CAST Mobile App iOS + Android |
| 4 | 07290017025063 | 01 | MPU-EG00C01 | 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. | LLZ | System, Image Processing, Radiological | 2 | Foot Pedal |
| 5 | 07290017025049 | 01 | MCU-EG00408 | LLZ | System, Image Processing, Radiological | 2 | Orpheus CAST w/o Display OD Unit | |
| 6 | 07290017025025 | 01 | MCU-EG00402 | 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. | LLZ | System, Image Processing, Radiological | 2 | Orpheus CAST 24 inch HD Unit |
| 7 | 07290017025018 | 01 | MCU-EG00401 | 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. | LLZ | System, Image Processing, Radiological | 2 | Orpheus CAST 22 inch |
| 8 | 07290017025056 | 01 | MVU-EG00D01 | Multi viewer video switch | LLZ | System, Image Processing, Radiological | 2 | Orpheus Switch |
| 9 | 07290017025117 | 01 | MSU-EG30001 | 3rd party rack external server | LLZ | System, Image Processing, Radiological | 2 | Orpheus VOD CSS |
| 10 | 07290017025070 | 01 | MCU-EG00405 | LLZ | System, Image Processing, Radiological | 2 | Bar Code Reader | |
| 11 | 07290017025001 | 01 | MVD-0001 | 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. | LLZ | System, Image Processing, Radiological | 2 | Orpheus System |
| 12 | 07290017025032 | 01 | MCU-EG00407 | 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. | LLZ | System, Image Processing, Radiological | 2 | Orpheus CAST 15 inch |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00066714700155 | V8 | CADI | Cadi Software | Cadi | SYNCA MARKETING INC |
| 2 | 00046838076619 | CCL650i2/AR | JVC | JVC KENWOOD CORPORATION | ||
| 3 | 00046838076602 | CCL650i2/N | JVC | JVC KENWOOD CORPORATION | ||
| 4 | 00046838076596 | CCL258i2/F | JVC | JVC KENWOOD CORPORATION | ||
| 5 | 00046838076589 | CCL258i2/AR | JVC | JVC KENWOOD CORPORATION | ||
| 6 | 00046838076572 | CCL258i2/N | JVC | JVC KENWOOD CORPORATION | ||
| 7 | 00046838076565 | MS25i2/AR | JVC | JVC KENWOOD CORPORATION | ||
| 8 | 00046838076558 | MS25i2/N | JVC | JVC KENWOOD CORPORATION | ||
| 9 | 00046838076541 | MS25i2/F | JVC | JVC KENWOOD CORPORATION | ||
| 10 | 00046838076534 | MS35i2/AR | JVC | JVC KENWOOD CORPORATION | ||
| 11 | 00046838076527 | MS35i2/N | JVC | JVC KENWOOD CORPORATION | ||
| 12 | 00046838076510 | MS35i2/F | JVC | JVC KENWOOD CORPORATION | ||
| 13 | 00046838076367 | CCL358i2/F | JVC | JVC KENWOOD CORPORATION | ||
| 14 | 00046838076350 | CCL358i2/N | JVC | JVC KENWOOD CORPORATION | ||
| 15 | B940IVZBKIT0 | ImmersiveTouch4 | ImmersiveTouch4 is a hardware accessory to ImmersiveTouch simulator. It supports ImmersiveTouch4 is a hardware accessory to ImmersiveTouch simulator. It supports ImmersiveTouch simulator to function as pre-operative software for simulating and evaluating surgical treatment options. | ImmersiveTouch | IMMERSIVETOUCH, INC. | |
| 16 | B940IMMERSIVEVIEW0 | V3.0 | The ImmersiveTouch simulators are intended as pre-operative software for simulat The ImmersiveTouch simulators are intended as pre-operative software for simulating and evaluating surgical treatment options. | ImmersiveTouch | IMMERSIVETOUCH, INC. | |
| 17 | B843UNISYN6110 | 6-1-1-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 18 | B843UNISYN5610 | 5-6-1-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 19 | B843UNISYN5520 | 5-5-2-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 20 | B843UNISYN5510 | 5-5-1-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 21 | B843UNISYN5410 | 5-4-1-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 22 | B843UNISYN531P20 | 5-3-1-P2 | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 23 | B843UNISYN431P10 | 4-3-1-P1 | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 24 | B843UNISYN425P20 | 4-2-5-P2 | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 25 | B80731 | Breast MRI SE | 3 | QuantX is a software program that is used to view and analyze patient breast images. | QuantX | QLARITY IMAGING, LLC |
| 26 | B80721 | Breast MRI Biopsy Guidance Plugin | 2 | The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assi The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assists users of the QuantX software device in planning MRI guided interventional procedures. | QuantX | QLARITY IMAGING, LLC |
| 27 | B801THINQ1130 | 1.1.3 | THINQ | CORTICOMETRICS LLC | ||
| 28 | B801THINQ1000 | 1.0.0 | THINQ | CORTICOMETRICS LLC | ||
| 29 | B7671R522 | 5.2.2 | Rapid | Rapid System Update | Rapid | ISCHEMAVIEW, INC. |
| 30 | B7671R521 | 5.2.2 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
| 31 | B7671R520 | 5.2.0 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
| 32 | B7671R512 | 5.1.2 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
| 33 | B7671R511 | 5.1.1 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
| 34 | B7671R5030 | 5.0.3 | Rapid | ISCHEMAVIEW, INC. | ||
| 35 | B761RAPID510 | 5.1 | Rapid 5.1 | Rapid | ISCHEMAVIEW, INC. | |
| 36 | B761RAPID50210 | 5.0.2.1 | Rapid | Rapid | RAPID | ISCHEMAVIEW, INC. |
| 37 | B761RAPID5020 | 5.0.2 | RAPID | ISCHEMAVIEW, INC. | ||
| 38 | B761RAPID5010 | 5.0.1 | RAPID | ISCHEMAVIEW, INC. | ||
| 39 | B761RAPID500 | 5.0 | Rapid | Rapid | RAPID | ISCHEMAVIEW, INC. |
| 40 | B761RAPID49101 | 4.9.1 | Rapid | Rapid | RAPID | ISCHEMAVIEW, INC. |
| 41 | B761RAPID48302 | 4.8.3 | RAPID | RAPID is a Platform for brain image analysis. | RAPID | ISCHEMAVIEW, INC. |
| 42 | B745VASCUCAPA2 | A.2 | vascuCAP | ELUCID BIOIMAGING INC. | ||
| 43 | B745ELUCIDVIVOA3 | A.3 | ElucidVivo | ELUCID BIOIMAGING INC. | ||
| 44 | B745A40 | A.1.2 | vascuCAP | ELUCID BIOIMAGING INC. | ||
| 45 | B725INITVV12 | 1.2 | INITVV | Visualize:Vascular is software that renders 3D images of vascular segments from Visualize:Vascular is software that renders 3D images of vascular segments from ultrasound imaging. | Visualize:Vascular | SALIENT IMAGING |
| 46 | B688IMAGEQUBE0 | ImageQube | ImageQube, Intuitive Imaging Informatics Picture Archiving and Communication Sy ImageQube, Intuitive Imaging Informatics Picture Archiving and Communication System (PACS), is a medical imaging information system that securely transmits, receives, and archives digitally transmitted images and provides radiologists access to patient information, medical images, annotated print pages, transcribed reports. | ImageQube | INTUITIVE IMAGING INFORMATICS, LLC | |
| 47 | B664CVM20 | CVM2 | Arterys Cardio DL | ARTERYS INC. | ||
| 48 | B664AVM30 | AVM3 | Arterys Viewer | ARTERYS INC. | ||
| 49 | B664AOM40 | AOM4 | Arterys Oncology DL | ARTERYS INC. | ||
| 50 | B664AMM60 | AMM6 | Arterys MICA | ARTERYS INC. |