| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00854904006008 | Synapse Radiology PACS Software License | Synapse, Fujifilm Picture Archiving and Communication Software (PACS), is a medi Synapse, Fujifilm Picture Archiving and Communication Software (PACS), is a medical imaging and information management system that helps radiologists archive and distribute the vast amounts of image information that are handled by their offices each day. | LLZ | System, image processing, radiological | 2 | Synapse Radiology PACS | |
| 2 | 00860007188329 | UST-9150 | Ultrasound Laparoscopic Probe | IYO,ITX,IYN | System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,Syst System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Doppler, Ultrasonic | 2 | UST-9150 | |
| 3 | 00860007188312 | UST 5550-R | Ultrasound Robotic Probe | IYO,ITX,IYN | System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,Syst System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Doppler, Ultrasonic | 2 | UST 5550-R | |
| 4 | 00854904006060 | Synapse Enterprise Viewer | Synapse Enterprise Viewer (EV) is a software-based enterprise image viewer used Synapse Enterprise Viewer (EV) is a software-based enterprise image viewer used with general purpose servers and dedicated reading workstations. It allows for communication, reformatting, rendering on the server component and communication and display of DICOM and non-DICOM images as well as reports. | LLZ | System, image processing, radiological | 2 | Synapse Enterprise Viewer | |
| 5 | 00854904006022 | Synapse MPR Fusion Software License | Synapse MPR/Fusion software enables the display, comparison and fusion of 3D (MI Synapse MPR/Fusion software enables the display, comparison and fusion of 3D (MIP/MPR) of CT, MR, PET and SPECT studies. Typical users are radiologists, technologists and clinicians. Synapse MPR/Fusion is not intended for Mammography use. | LLZ | System, image processing, radiological | 2 | Synapse MPR Fusion | |
| 6 | 00869047000431 | 4.X.X | The VidiStar PACS & DICOM Viewer Software system is a picture archiving and comm The VidiStar PACS & DICOM Viewer Software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The VidiStar PACS & DICOM Viewer Software is comprised of modular software programs that run on standard “off-the-shelf” personal computers, business computers, and servers running standard operating systems. VidiStar PACS & DICOM Viewer Software system is an image, data storage and display software that accepts DICOM data from laboratories, which support DICOM standard imaging data and structured reporting transfer(s). The system provides the capability to: organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, perform quantitative measurements, and create DICOM structure reports, all over the Internet. | DQK,LLZ | Computer, Diagnostic, Programmable,System, Image Processing, Radiological | 2 | VidiStar PACS & DICOM Viewer Software | |
| 7 | 00860007188305 | C9150LA | 4-way Laparoscopic Ultrasound Transducer/Smart Connector | IYO,ITX,IYN | System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,Syst System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Doppler, Ultrasonic | 2 | C9150LA | |
| 8 | 00854904006053 | Synapse Mobility Base Package | Synapse Mobility is a feature-rich DICOM and Non-DICOM image and report viewer. Synapse Mobility is a feature-rich DICOM and Non-DICOM image and report viewer. Synapse Mobility utilizes the latest server side rendering technology to stream imaging securely and fast to any authorized user, with the ability to open within applications, directly from your EHR, or on our mobile device apps. | LLZ | System, image processing, radiological | 2 | Synapse Mobility | |
| 9 | 00854904006015 | Synapse Cardiology PACS Software License | Developed with direction from cardiologists, Synapse Cardiovascular offers capab Developed with direction from cardiologists, Synapse Cardiovascular offers capabilities and tools that help streamline workflow, image review, and reporting for a variety of cardiac areas. | LLZ | System, image processing, radiological | 2 | Synapse Cardiology PACS | |
| 10 | 00869047000448 | C9150LA | Ultrasound transducer | IYO,ITX,IYN | System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,Syst System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Doppler, Ultrasonic | 2 | HITACHI HEALTHCARE AMERICAS | |
| 11 | 00869047000424 | UST-52114P-B | Ultrasound Transducer | IYO,ITX,IYN | System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,Syst System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Doppler, Ultrasonic | 2 | HITACHI HEALTHCARE AMERICAS | |
| 12 | 00869047000417 | UST-9150 | Ultrasound transducer | IYO,ITX,IYN | System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,Syst System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Doppler, Ultrasonic | 2 | HITACHI HEALTHCARE AMERICAS | |
| 13 | 00860007188336 | UST-52114P-B | Ultrasound Brainpath Probe | IYO,ITX,IYN | System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,Syst System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Doppler, Ultrasonic | 2 | UST-52114P-B | |
| 14 | 00869047000462 | DK-STAND-KIT | System Arm, Stabilizer, Stepper & Stand | IWJ | System, Applicator, Radionuclide, Manual | 1 | D&K Technologies | |
| 15 | 00869047000455 | DK-ARM-KIT | System Arm, Stabilizer, Stepper & Stand | IWJ | System, Applicator, Radionuclide, Manual | 1 | D&K Technologies | |
| 16 | 00860007188343 | S12BP4 | Transducer S12BP4 – 11 mm Neurosurgery Probe | IYO,ITX,IYN | System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,Syst System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Doppler, Ultrasonic | 2 | Transducer S12BP4 |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00184360000709 | 806302012 | s5i Control Console | VOLCANO CORPORATION | ||
| 2 | 00184360000686 | 807401001 | s5i Imaging System Workstation | VOLCANO CORPORATION | ||
| 3 | 00184360000525 | 807301001 | s5 PC Module | VOLCANO CORPORATION | ||
| 4 | 00184360000327 | R100 | 804547001 | R-100 Pullback Device | VOLCANO CORPORATION | |
| 5 | 00092237617281 | LS5288L1 | Conductive Ultrasound Gel - | LG | COMPASS HEALTH BRANDS CORP. | |
| 6 | 00092237617274 | LS5266L1 | Conductive Ultrasound Gel - | LG | COMPASS HEALTH BRANDS CORP. | |
| 7 | 00092237613269 | LS5266 | TheraSonic Conductive Gel, 16- | N/A | COMPASS HEALTH BRANDS CORP. | |
| 8 | 00092237613252 | LS5288 | TheraSonic Conductive Gel, 8-o | N/A | COMPASS HEALTH BRANDS CORP. | |
| 9 | 00092237613245 | LC2828 | TheraSonic Conductive Gel, 2-o | N/A | COMPASS HEALTH BRANDS CORP. | |
| 10 | 00092237611531 | LS5255 | TheraSonic Conductive Gel, 5L | N/A | COMPASS HEALTH BRANDS CORP. | |
| 11 | 00083059012071 | 1207 | The Aware™ Pad is intended to be used as an aid for performing breast self-examination. | Aware Breast Self-Exam Pad | BIOMERICA, INC. | |
| 12 | 00083059012033 | 1203 | The Aware™ Pad is intended to be used as an aid for performing breast self-examination. | Aware Breast Self-Exam Pad | BIOMERICA, INC. | |
| 13 | 00035135013052 | CTR001305 | CTR001305 | GEL,ULTRASOUND,BOTTLE,8.5-OZ,CLEAR | MEDLINE INDUSTRIES, INC. | MEDLINE INDUSTRIES, INC. |
| 14 | B995LI10050 | LI-1005 | Velacur is a portable ultrasonic elastography machine used to assess and monitor Velacur is a portable ultrasonic elastography machine used to assess and monitor chronic liver diseases. The device is comprised of a control unit, activation unit, and ultrasound probe. A carrying case is also provided. | Velacur | SONIC INCYTES MEDICAL CORP. | |
| 15 | B995LI10050 | LI-1005 | Velacur is a portable ultrasonic elastography machine used to assess and monitor Velacur is a portable ultrasonic elastography machine used to assess and monitor chronic liver diseases. The device is comprised of a control unit, activation unit, and ultrasound probe. A carrying case is also provided. | Velacur | SONIC INCYTES MEDICAL CORP. | |
| 16 | B748AR350050DUS0 | AR-3500-50D-US | Sterile ultrasound probe cover and ultrasound gel. | Synergy MSK Ultrasound Strl Cover & Parker Gel | SAFERSONIC MEDIZINPRODUKTE HANDELS GMBH | |
| 17 | B748AR350050DEU0 | AR-3500-50D-US | Sterile ultrasound probe cover and ultrasound gel. | Synergy MSK Ultrasound Strl Cover & Parker Gel | SAFERSONIC MEDIZINPRODUKTE HANDELS GMBH | |
| 18 | B616UVXS0 | XS | General Purpose Diagnostic Medical Ultrasonic Imaging System | UltraVision | ULTRAVISION CORPORATION | |
| 19 | B616UVXR0 | XR | General Purpose Diagnostic Medical Ultrasonic Imaging System | UltraVision | ULTRAVISION CORPORATION | |
| 20 | B616UVXP0 | XP | General Purpose Diagnostic Medical Ultrasonic Imaging System | UltraVision | ULTRAVISION CORPORATION | |
| 21 | B616UVXC0 | XC | General Purpose Diagnostic Ultrasonic Imaging System | UltraVision | ULTRAVISION CORPORATION | |
| 22 | B616UVTKL1440 | Konica Linear Probe L14-4 | n/a | Linear Ultrasonic Transducer | UltraVision | ULTRAVISION CORPORATION |
| 23 | B616UVTKHL1840 | Konica Hockey Stick Linear 18-4 | n/a | Linear Ultrasonic Transducer | UltraVision | ULTRAVISION CORPORATION |
| 24 | B616UVTKCC520 | Konica Curved Probe C5-2 | n/a | Curved Ultrasonic Transducer | UltraVision | ULTRAVISION CORPORATION |
| 25 | B510DUS70000 | DUS-7000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
| 26 | B510DUS70000 | DUS-7000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
| 27 | B510DUS70000 | DUS-7000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
| 28 | B510DUS5000A1 | DUS-5000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
| 29 | B510DUS5000A1 | DUS-5000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
| 30 | B510DUS5000A1 | DUS-5000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
| 31 | B510DUS30001 | DUS-3000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
| 32 | B510DUS30001 | DUS-3000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
| 33 | B41278000 | 1 | 7800 | The Varia Transcranial Doppler Ultrasound (TCD) device provides precision measur The Varia Transcranial Doppler Ultrasound (TCD) device provides precision measurements of cerebrovascular blood flow. Designed to exacting standards, Varia delivers excellent signal quality with minimal ambient noise, allowing clinicians to easily locate vessels and obtain high-quality measurements. When attached to an external MS Windows-based computer, Varia presents the clinician with an intuitive interface including clear displays and easy-to-use input parameters to facilitate a quality exam.Utilized with software only device accessory Varia-NCI. | Varia TCD | NEUROCHAOS SOLUTIONS INC |
| 34 | B41278000 | 1 | 7800 | The Varia Transcranial Doppler Ultrasound (TCD) device provides precision measur The Varia Transcranial Doppler Ultrasound (TCD) device provides precision measurements of cerebrovascular blood flow. Designed to exacting standards, Varia delivers excellent signal quality with minimal ambient noise, allowing clinicians to easily locate vessels and obtain high-quality measurements. When attached to an external MS Windows-based computer, Varia presents the clinician with an intuitive interface including clear displays and easy-to-use input parameters to facilitate a quality exam.Utilized with software only device accessory Varia-NCI. | Varia TCD | NEUROCHAOS SOLUTIONS INC |
| 35 | B412779815 | 1 | 7798 | Varia-NCI accesses data from Varia TCD, a digital Transcranial Doppler (TCD) Ult Varia-NCI accesses data from Varia TCD, a digital Transcranial Doppler (TCD) Ultrasound device. Varia-NCI is an intuitive software program that provides clinicians information on a patient’s cerebrovascular regulation by reporting key physiologic parameters, including the Neurovascular Complexity Index (NCI). Through high performance analytical processing of a TCD recording, it delivers quantitative Cerebral Blood Flow Velocity (CBFV) variability results to clinicians managing head trauma. Varia-NCI is an accessory application to the Varia TCD device.Software only device and accessory to Varia TCD. | Varia-NCI | NEUROCHAOS SOLUTIONS INC |
| 36 | B377GMD61VASUS40 | Vascular V4 | GMD61VASUS4 | USB ultrasound probe, general purpose/vascular | ClearProbe | GLOBALMEDIA GROUP, LLC |
| 37 | B377GMD61VASUS40 | Vascular V4 | GMD61VASUS4 | USB ultrasound probe, general purpose/vascular | ClearProbe | GLOBALMEDIA GROUP, LLC |
| 38 | B377GMD61ENDUS40 | Endocavity V4 | GMD61ENDUS4 | USB ultrasound probe, general purpose/endocavity. | ClearProbe | GLOBALMEDIA GROUP, LLC |
| 39 | B377GMD61ENDUS40 | Endocavity V4 | GMD61ENDUS4 | USB ultrasound probe, general purpose/endocavity. | ClearProbe | GLOBALMEDIA GROUP, LLC |
| 40 | B377GMD61ABDUS40 | Abdominal V4 | GMD61ABDUS4 | USB ultrasound probe, general purpose/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
| 41 | B377GMD61ABDUS40 | Abdominal V4 | GMD61ABDUS4 | USB ultrasound probe, general purpose/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
| 42 | B377GMD6180NV010 | Neonatal | GMD6180NV01 | USB ultrasound probe, general purpose/neonatal | ClearProbe | GLOBALMEDIA GROUP, LLC |
| 43 | B377GMD6180NV010 | Neonatal | GMD6180NV01 | USB ultrasound probe, general purpose/neonatal | ClearProbe | GLOBALMEDIA GROUP, LLC |
| 44 | B377GMD6175VA010 | Vascular | GMD6175VA01 | USB ultrasound probe, general purpose/vascular | ClearProbe | GLOBALMEDIA GROUP, LLC |
| 45 | B377GMD6175VA010 | Vascular | GMD6175VA01 | USB ultrasound probe, general purpose/vascular | ClearProbe | GLOBALMEDIA GROUP, LLC |
| 46 | B377GMD6175RV010 | Endocavity | GMD6175RV01 | USB ultrasound probe, general purpose/endocavity | ClearProbe | GLOBALMEDIA GROUP, LLC |
| 47 | B377GMD6175RV010 | Endocavity | GMD6175RV01 | USB ultrasound probe, general purpose/endocavity | ClearProbe | GLOBALMEDIA GROUP, LLC |
| 48 | B377GMD6150AB010 | Abdominal 5 MHz | GMD6150AB01 | USB ultrasound probe, general use/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
| 49 | B377GMD6150AB010 | Abdominal 5 MHz | GMD6150AB01 | USB ultrasound probe, general use/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
| 50 | B377GMD6135AB020 | Abdominal 3 MHz | GMD6135AB02 | USB ultrasound probe, general purpose/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |