| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00856100006264 | 1.1 | MUJ | System, planning, radiation therapy treatment | 2 | Ethos™ Treatment Planning | ||
| 2 | 00856100006233 | 1.1 | MUJ | System, planning, radiation therapy treatment | 2 | Varian AI Segmentation | ||
| 3 | 00856100006172 | 1.0 | MUJ | System, planning, radiation therapy treatment | 2 | Varian AI Segmentation | ||
| 4 | 00858086006597 | 88928505 | IYE | Accelerator, linear, medical | 2 | Varian E-ARC Aperture Tray Assay | ||
| 5 | 00858086006283 | P1006801006 | Contains one 10858086006266 Cranial Screws, Long, Pouch of 2 and one 10858086006 Contains one 10858086006266 Cranial Screws, Long, Pouch of 2 and one 10858086006273 Cranial Screws, Short, Pouch of 2 | IYE | Accelerator, linear, medical | 2 | Head Frame Cranial Screws - Long and Short | |
| 6 | 00856545006010 | 2.1 | TM64001000 | KPQ | System, simulation, radiation therapy | 2 | Varian Acuity with Conebeam Computed Tomography | |
| 7 | 00856100006165 | 16.1 | IYE | Accelerator, linear, medical | 2 | ARIA Radiation Therapy Management (RTM) | ||
| 8 | 00850011006122 | 2 | ASM0341 | IYE | Accelerator, linear, medical | 2 | Calypso Beacon Care Package-Lung | |
| 9 | 00816389028319 | GM11002260 | GM11002260 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Bronchial catheter, ø 1.84 mm, sterile | |
| 10 | 00816389027862 | GM11013300 | GM11013300 | Contains: GM11013310-00816389027879, GM11013320-00816389027886, GM11013330-00816 Contains: GM11013310-00816389027879, GM11013320-00816389027886, GM11013330-00816389027893, GM11013340-00816389027909 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Varian Universal Interstitial Cylinder Set |
| 11 | 00816389026391 | GM13002560 | GM13002560 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | PermaDoc GMplus+Source Guide Tube | |
| 12 | 00816389025622 | GM11010760 | GM11010760 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Source guide tube light with locking mechanism for 320 mm needles, GammaMedplus | |
| 13 | 00816389025578 | GM11010710 | GM11010710 | For Titanium Fletcher-style Applicator Set Defined Geometry | JAQ | System, applicator, radionuclide, remote-controlled | 2 | 3D-FSD interstitial ovoid pair for 20mm spread with 4 needle guide holes/ovoid |
| 14 | 00816389024281 | GM11007620 | GM11007620 | For GammaMedplus channel 2 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Source guide tube with locking mechanism, third-party applicator |
| 15 | 00816389022454 | GM11003040 | GM11003040 | for Flexible Interstitial Implant Tube Set, plus GM11008570-8580 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Pushing device for implant needle, 1.7 mm diameter |
| 16 | 10816389028804 | Channel 30 | Not Sold Separately | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Leak Stop Channel Marker - Channel 30 - 25 pack | |
| 17 | 00810563020960 | DP35-0215-102 | CRYO-48-F | Straight 8mm cryoprobefor use with Cryocare systems (Lead-Free) | OCL | Surgical Device, For cutting, coagulation, and/or ablation of tissue, including Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue | 2 | 8mm Cryoprobe |
| 18 | 00810563020953 | DP35-0215-101 | CRYO-48-F | Straight 8mm cryoprobe for use with Cryocare Systems | OCL | Surgical Device, For cutting, coagulation, and/or ablation of tissue, including Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue | 2 | 8mm Cryoprobe |
| 19 | 10816389028521 | Channel 3 | Not Sold Separately | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Leak Stop Channel Marker - Channel 3 - 25 pack | |
| 20 | 10816389028514 | Channel 2 | Not Sold Separately | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Leak Stop Channel Marker - Channel 2 - 25 pack | |
| 21 | 10816389028217 | GM11003220 | GM11003220 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Varian Brachytherapy Cleaning Caps, black (pack of 20) | |
| 22 | 00899475002325 | 8.5 | IYE | Accelerator, linear, medical | 2 | 80 Leaf Assy, MLC Head | ||
| 23 | 00899475002363 | 3.0 | IYE | Accelerator, linear, medical | 2 | VitalBeam | ||
| 24 | 00899475002455 | 1.0 | IXG | Phantom, anthropomorphic, radiographic | 1 | End-To-End SRS Head Phantom | ||
| 25 | 00899475002240 | 2.7 | IYE | Accelerator, linear, medical | 2 | VitalBeam Radiotherapy System | ||
| 26 | 00899475002219 | 9.1 | IYE | Accelerator, linear, medical | 2 | Trilogy TX Image-Guided Radiosurgery | ||
| 27 | 00899475002196 | P1006805002 | Head Frame Kit, Couch Adapter, SCCB, 20 Short + 20 Long Cranial Screws | IYE | Accelerator, linear, medical | 2 | Varian Head Frame Package | |
| 28 | 00899475002165 | P1006801003 | Cranial screw - short+long box Qty 4 (2 each) | IYE | Accelerator, linear, medical | Cranial Screw - Short/Long | ||
| 29 | 00899475002011 | 2.5 | IYE | Accelerator, linear, medical | 2 | VitalBeam | ||
| 30 | 00857235006051 | 3.1 | IYE | Accelerator, linear, medical | 2 | Halcyon | ||
| 31 | 00816389027893 | GM11013330 | GM11013330 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Varian Universal Interstitial Cylinder, 35mm diameter | |
| 32 | 00850011006115 | 3 | ASM0195 | The Calypso System utilizes non-ionizing electromagnetic and optical technology The Calypso System utilizes non-ionizing electromagnetic and optical technology to provide accurate, objective, and continuous localization of a treatment target for patient alignment and target position monitoring during radiation therapy. Use of the Calypso System for target localization is based on the system’s detection of electromagnetic signals from passive implanted markers, called Beacon transponders. The Beacon transponders are placed on the patient’s skin surface or implanted in or near the treatment target. When used with the Calypso System, the Beacon transponder signals enable objective, continuous measurement of the localization of the treatment target in 3 dimensions. The system operator uses this information for patient alignment and continuous target positioning (i.e., tracking) during radiation therapy treatment. | IYE | Accelerator, Linear, Medical | 2 | Calypso System |
| 33 | 00816389027824 | GM11011410 | GM11011410 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Varian Universal Multi-channel Cylinder, 25mm diameter | |
| 34 | 00816389021990 | GM11001430 | GM11001430 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Wall holder for source and transfer guide tubes | |
| 35 | 00810563021059 | DP35-0942-202 | PCS-17 | Right angle 1.7mm cryoprobe, oblong ice, for use with Cryocare systems | GEH | UNIT, CRYOSURGICAL, ACCESSORIES | 2 | 1.7 mm PerCryo™ Cryoprobe |
| 36 | 00810563021028 | 22-17025-025 | SW-1425 | Long Tip Microwave Antenna Kit (25 cm, 1 per Tray) | NEY | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES | 2 | SynchroWave LT Antenna |
| 37 | 00810563021011 | 22-17025-020 | SW-1420 | Long Tip Microwave Antenna Kit (20 cm, 1 per Tray) | NEY | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES | 2 | SynchroWave LT Antenna |
| 38 | 00810563021004 | 22-17025-015 | SW-1415 | Long Tip Microwave Antenna Kit (15 cm, 1 per Tray) | NEY | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES | 2 | SynchroWave LT Antenna |
| 39 | 00810563020908 | DP40-0015-213 | CRYO-55-F | Temperature probe | GEH | UNIT, CRYOSURGICAL, ACCESSORIES | 2 | TempProbe™ Device |
| 40 | 00810563020694 | DP35-0942-207 | PCS-17 | Right angle 1.7mm cryoprobe, oblong ice, for use with Cryocare systems (Lead-Free) | GEH | UNIT, CRYOSURGICAL, ACCESSORIES | 2 | 1.7 mm PerCryo™ Cryoprobe |
| 41 | 10816389028767 | Channel 26 | Not Sold Separately | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Leak Stop Channel Marker - Channel 26 - 25 pack | |
| 42 | 10816389028729 | Channel 22 | Not Sold Separately | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Leak Stop Channel Marker - Channel 22 - 25 pack | |
| 43 | 10816389028705 | Channel 20 | Not Sold Separately | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Leak Stop Channel Marker - Channel 20 - 25 pack | |
| 44 | 10816389028699 | Channel 19 | Not Sold Separately | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Leak Stop Channel Marker - Channel 19 - 25 pack | |
| 45 | 10816389028682 | Channel 18 | Not Sold Separately | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Leak Stop Channel Marker - Channel 18 - 25 pack | |
| 46 | 10816389028552 | Channel 6 | Not Sold Separately | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Leak Stop Channel Marker - Channel 6 - 25 pack | |
| 47 | 10816389028200 | GM11003360 | GM11003360 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Brachytherapy Cleaning caps, black (pack of 20) (interstitial tube connector) | |
| 48 | 00899475002318 | 8.5 | IYE | Accelerator, linear, medical | 2 | HD 120 MLC Head Assembly | ||
| 49 | 00899475002493 | 10002738503 | IYE | Accelerator, linear, medical | 2 | Varian POST ASSY, STEREOTACTIC HEAD FRAME | ||
| 50 | 00899475002394 | 2.0 | P1006805003 | IYE | Accelerator, linear, medical | 2 | VARIAN HEAD FRAME KIT |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00858846007222 | CMDR.TW.1202.R | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 2 | 00858846007215 | CMDR.PE.1202.S | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 3 | 00858846007208 | CMDR.PE.120.60.S | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 4 | 00858846007192 | CMDR.TW.120.60.R | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 5 | 00858846007185 | CMDR.PE.100.R | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 6 | 00858846007178 | Integris | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 7 | 00858846007161 | CMDR.PE.120.60.R | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 8 | 00858846007154 | CMDR.TW.120.60.S | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 9 | 00858846007147 | CMDR.T.100.S | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 10 | 00858846007130 | CMDR.TW.100.R | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 11 | 00858846007123 | CMDR.TW.1202.S | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 12 | 00858846007116 | CMDR.T.1202.R | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 13 | 00858846007109 | CMDR.T.1202.S | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 14 | 00858846007093 | CMDR.TW.100.S | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 15 | 00858846007086 | CMDR.T.100.R | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 16 | 00858846007079 | CMDR.PE.1202.R | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 17 | 00858846007062 | CMDR.PE.100.S | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 18 | 00858846007055 | CMDR.T.120.60.S | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 19 | 00858846007048 | CMDR.T.120.60.R | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 20 | 00858846007031 | CMDR-2SLWT | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 21 | 00858701006018 | SQ3500 | SPY-Q™ or SPY-QCM™ | NOVADAQ TECHNOLOGIES INC | ||
| 22 | 00858012005922 | V3.4 | D70141, D70142, D70160 | "PowerLook Density Assessment 3.4 is a software application intended for use wit "PowerLook Density Assessment 3.4 is a software application intended for use with DBT 2D images from tomosynthesis exams. PowerLook Density Assessment 3.4 provides a BI-RADS 5th Edition breast density category to aid health care professionals in the assessment of breast tissue composition. PowerLook Density Assessment 3.4 produces adjunctive information. It is not a diagnostic aid. | PowerLook Density Assessment V3.4 | ICAD, INC. |
| 23 | 00858012005786 | 3.5 | D4D0185 | The DynaCAD 3 software consists of the MR Analysis Server software and the viewe The DynaCAD 3 software consists of the MR Analysis Server software and the viewer workstation software.The MR Analysis Server software, which includes the DynaCAD Breast, DynaCAD Prostate, and DynaCAD Advanced PK for other MR Analysis modules, is intended to be used as a post-processing software package designed to provide a reliable means for analyzing MR datasets. The software facilitates the analysis of dynamic and non-dynamic MR datasets to provide study review and additional mathematical and/or statistical analysis. The resulting analysis can be displayed in a variety of formats, including parametric images overlaid onto source MRI images.The viewer workstation software is intended for use in conjunction with the MR Analysis Server software and facilitates the analysis and presentation of datasets generated by the MR Analysis Server software and incorporates the following functions: Region of Interest (ROI) curve, Pixel of Interest (POI) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities.DynaCAD 3 software serves as a workflow roadmap tool that organizes and guides the radiologist through the series of sequential tasks that must be performed in order to arrive at a diagnosis. The specific configuration of product features drives the DynaCAD 3 software underlying workflow solution for lesion characterization and reporting. This inherent workflow regimen integrates easily into the radiologist‘s existing departmental workflow and can be adapted to fit the needs of each user, thereby streamlining diagnosis. In the hands of a trained physician the information provided by the data analysis could yield information that may assist in the interpretation of dynamic and non-dynamic MR studies. | DynaCAD | ICAD, INC. |
| 24 | 00858012005779 | 3.5 | D75014-05, D57015-05 | The DynaLOC Breast Interventional Planning software module supports the use of M The DynaLOC Breast Interventional Planning software module supports the use of MR interventional breast coils and localization devices to perform MR-guided breast interventional procedures. Using information from MR images regarding the coordinates of a user-specified region of interest, and fiducial coordinates, the software provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion, relative to the interventional device.The accuracy of DynaLOC software depends on the resolution of the acquired dataset. If the sum of the slice thicknesses for marker and target series does not exceed 5 mm, the 3-dimensional accuracy is 5 mm. Otherwise it is equal to the sum of two slice thicknesses for marker and target series. The accuracy can be negatively affected by any of the following: • Significant patient movement after the breast is securely immobilized in the biopsy device• Significant displacement of tissue during needle penetration • Image distortion in the MR dataset. | DynaLOC Breast Interventional Planning Software | ICAD, INC. |
| 25 | 00858012005656 | V2.1 | DSC012 | PowerLook Density Assessment software application intended for use with digital PowerLook Density Assessment software application intended for use with digital mammographysystems. PowerLook Density Assessment calculates breast density as a ratio of fibroglandular tissue andtotal breast area estimates. PowerLook Density Assessment provides these numerical values for eachbreast as well as a density category to aid radiologists in the assessment of breast tissuecomposition. PowerLook Density Assessment produces adjunctive information. It is not an interpretive ordiagnostic aid. | iReveal with PowerLook AMP | ICAD, INC. |
| 26 | 00858012005205 | V2.1 | D70124, D70141 and D70126 | PowerLook Density Assessment is a software application intended for use with dig PowerLook Density Assessment is a software application intended for use with digital mammographysystems. PowerLook Density Assessment calculates breast density as a ratio of fibroglandular tissue andtotal breast area estimates. PowerLook Density Assessment provides these numerical values for eachbreast as well as a density category to aid radiologists in the assessment of breast tissuecomposition. PowerLook Density Assessment produces adjunctive information. It is not an interpretive ordiagnostic aid. | iReveal Breast Density Assessment | ICAD, INC. |
| 27 | 00857926006001 | 4.20.300 | R4 ACERT | HYLAND SOFTWARE, INC. | ||
| 28 | 00857560008003 | 6.4.3 | 113-00749 | CardioPACS is a software device intended to be used by medical professionals for CardioPACS is a software device intended to be used by medical professionals for storage, review, query/ retrieve, analysis, and post processing of DICOM medical images that are generated by echocardiography, radiology, and other modalities. The device can be used as a stand-alone product or in a networked system. CardioPACS is not intended for use with mammograms. | HealthView CardioPACS | LUMEDX CORPORATION |
| 29 | 00857198006006 | V1 | Oasis is a software product designed to operate on an office PC. The product is Oasis is a software product designed to operate on an office PC. The product is intended for use by qualified medical personnel for the assessment of diagnostic medical images.The software allows for the processing, review, and transfer of scintigraphy camera output data as well as related diagnostic medical images produced by DICOM-based multimodality sources. These sources may include, but are not limited to, radiological diagnostic systems, picture archival computers (PACS), and processing workstations.Oasis is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs. The Oasis system displays processed images using an integrated computer. Oasis provides manual and automatic report creation plus the ability to view these reports remotely. Oasis also provides patient scheduling tools.The Oasis product is not intended to be used as a replacement for visual interpretation, nor as a diagnostic tool without the use of other clinical and laboratory information. | Oasis | SEGAMI CORPORATION | |
| 30 | 00857088008387 | ATEC Lateral Kit 3.0 | 900-3TX | The device consists of a sterile Snap that includes reflective features that fac The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. | TrackX | TRACKX TECHNOLOGY, LLC |
| 31 | 00857088008370 | ATEC Lateral Kit 2.0 | 900-3TX | The device consists of a sterile Snap that includes reflective features that fac The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. | TrackX | TRACKX TECHNOLOGY, LLC |
| 32 | 00857088008363 | ACCESS-LR1 SNAP | 800-3TX | The device consists of a sterile Snap that includes reflective features that fac The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. | TrackX | TRACKX TECHNOLOGY, LLC |
| 33 | 00857050006038 | 4.0 | Doctor's Reading Station | DigiView | DIGISONICS INC | |
| 34 | 00857050006021 | 4.9 | System, Image Processing, Radiological - Doctors Reading Station | OBView | DIGISONICS INC | |
| 35 | 00857050006014 | 4.8 | System, Image Processing, Radiological - Doctors reading Station | OBView | DIGISONICS INC | |
| 36 | 00857050006007 | 3.8 | Doctors Review Station - System, Image processing, Radiological | DigiView | DIGISONICS INC | |
| 37 | 00856571007258 | 10009-2 | 10009-2 | Archimedes Planning Software is software installed on a laptop computer used for Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths to the region of interest through both airways and lung tissue. | Archimedes Access Key, 10-pack | BRONCUS MEDICAL INC. |
| 38 | 00856571007227 | 10009-1 | 10009-1 | Archimedes Planning Software is software installed on a laptop computer used for Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths to the region of interest through both airways and lung tissue. | Archimedes Access Key | BRONCUS MEDICAL INC. |
| 39 | 00856571007173 | 30005 | 30005 | LungPoint VBN Software is software installed on a desktop computer used to plan LungPoint VBN Software is software installed on a desktop computer used to plan procedures and navigate to targets in the lung. The LungPoint Procedure Program offers real-time navigation guidance for use during the bronchoscopy procedure. The software allows visualization of the bronchial tree; helps guide the tools in or adjacent to the bronchial tree; allows visualization of a predefined target in lung tissue; and assists with placement of markers into soft lung tissue to guide radiosurgery and thoracic surgery. | LungPoint VBN System, V3.2 | BRONCUS MEDICAL INC. |
| 40 | 00856571007128 | 30009 | 30009 | LungPoint Planning Software is software installed on a laptop computer used for LungPoint Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths to the region of interest through both airways and lung tissue. | LungPoint Planning System, v3.2 | BRONCUS MEDICAL INC. |
| 41 | 00856571007104 | 40009 | 40009 | Archimedes Planning Software is software installed on a laptop computer used for Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths on the computer or printed plan to the region of interest through both airways and lung tissue. | Archimedes Planning System | BRONCUS MEDICAL INC. |
| 42 | 00856571007036 | 40005 | 40005 | Archimedes software is installed on a desktop computer used to plan procedures a Archimedes software is installed on a desktop computer used to plan procedures and navigate to targets in the lung. The Procedure Module offers real-time navigation guidance for use during the bronchoscopy procedure. The Software provides the option to segment previously acquired CT or other DICOM data sets and overlay and register these segmented data sets onto live fluoroscopic X-ray images. The software allows visualization of the bronchial tree; helps guide the tools in or adjacent to the bronchial tree; allows visualization of a predefined target in lung tissue; and assists with placement of markers into soft lung tissue to guide radiosurgery and thoracic surgery. | Archimedes System | BRONCUS MEDICAL INC. |
| 43 | 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. | Synapse Enterprise Viewer | FUJIFILM HEALTHCARE AMERICAS CORPORATION | |
| 44 | 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. | Synapse Mobility | FUJIFILM HEALTHCARE AMERICAS CORPORATION | |
| 45 | 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. | Synapse MPR Fusion | FUJIFILM HEALTHCARE AMERICAS CORPORATION | |
| 46 | 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. | Synapse Cardiology PACS | FUJIFILM HEALTHCARE AMERICAS CORPORATION | |
| 47 | 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. | Synapse Radiology PACS | FUJIFILM HEALTHCARE AMERICAS CORPORATION | |
| 48 | 00854393006022 | 4.1 | Velocity Medical Imaging Data Comparison Software | VARIAN MEDICAL SYSTEMS, INC. | ||
| 49 | 00854393006015 | 4.0 | Velocity Medical Imaging Data Comparison Software | VARIAN MEDICAL SYSTEMS, INC. | ||
| 50 | 00854393006008 | 3.2 | Velocity | VARIAN MEDICAL SYSTEMS, INC. |