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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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ViewBox Basic - B295VBB60

Basic radiologist workstation
Radius
6
In Commercial Distribution

  • B295VBB60 ()


  • Radiological PACS software

ViewBox Advanced - B295VBA10

Advanced radiologist workstation
Radius
1
In Commercial Distribution

  • B295VBA10 ()


  • Radiological PACS software

ConnectWeb with PACSCore - B295FULLPACS30

ConnectWeb viewer front-end with PACSCore back-end archive
Radius
3
In Commercial Distribution

  • B295FULLPACS30 ()


  • Radiological PACS software

PROTOS 3D IMRT Control & Analysis Software - B365118600

No Description
Aktina Corp.
11-860
In Commercial Distribution

  • B365118600 ()


  • Radiation therapy software

Codonics Safe Label System®(SLS) 550i Point of Care Station - 00814905020373

Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items - 143C
CODONICS INC.
550i PCS - 143C
In Commercial Distribution

  • 00814905020373 ()


  • Parenteral-nutrition management software

Codonics Safe Label System®(SLS) 550i Point of Care Station - 00814905020366

Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items
CODONICS INC.
550i PCS
In Commercial Distribution

  • 00814905020366 ()


  • Parenteral-nutrition management software

Codonics Safe Label System®(SLS) 500i Point of Care Station - 00814905020250

Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items-142C
CODONICS INC.
500i PCS -142C
In Commercial Distribution

  • 00814905020250 ()


  • Parenteral-nutrition management software

Codonics Safe Label System®(SLS) 500i Point of Care Station - 00814905020243

Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items-141C
CODONICS INC.
500i PCS -141C
In Commercial Distribution

  • 00814905020243 ()


  • Parenteral-nutrition management software

Codonics Safe Label System®(SLS) 500i Point of Care Station - 00814905020236

Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items-140C
CODONICS INC.
500i PCS -140C
In Commercial Distribution

  • 00814905020236 ()


  • Parenteral-nutrition management software

Codonics Safe Label System®(SLS) 500i Point of Care Station - 00814905020229

Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items
CODONICS INC.
500i PCS
In Commercial Distribution

  • 00814905020229 ()


  • Parenteral-nutrition management software

Codonics Safe Label System® Administration Tool - 00814905020144

Administration Tool compatible with Codonics Safe Label System® 500i Point of Care Station
CODONICS INC.
2.2.0
In Commercial Distribution

  • 00814905020144 ()


  • Parenteral-nutrition management software

Codonics Safe Label System® Administration Tool - 00814905020038

V2.1.0 Administration Tool compatible with Codonics Safe Label System® 500i Point of Care Station
CODONICS INC.
2.1.0
In Commercial Distribution

  • 00814905020038 ()


  • Parenteral-nutrition management software

Vessel Analysis for ORS Visual - B332VIVA0100

Vessel Analysis is a post-processing add-on module for ORS Visual that enables radiologists, cardiologists, vascular surgeons, and interventionalists to quickly and confidently evaluate CT angiographic studies. Vessel Analysis provides stenosis calculations, aneurysm quantification, and stent and stent-graft planning of the aorta, carotid, and renal arteries in an easy-to-use, intuitive screen that can simplify the clinical task of planning endovascular procedures. Advanced functionality such as automated vessel finding acts as a baseline for accurate vessel measurements and permits rapid segmentation of vessels. ORS Visual is a proprietary software application developed by Object Research Systems (ORS) Inc. that can be is used for the display and 3D visualization of medical image data derived from CT, MRI, and other modalities. It provides for the communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data. ORS Visual, which is available in 32 and 64-bit versions, can be installed on a standard personal computer running the Windows operating system with the Microsoft ActiveX component and suitable graphics hardware.
Object Research Systems (ORS) Inc
ORS-VISU-VA01
In Commercial Distribution

  • B332VIVA0100 ()


  • Radiological PACS software

ORS Visual - B332VISU0105

ORS Visual is a proprietary software application developed by Object Research Systems (ORS) Inc. that can be is used for the display and 3D visualization of medical image data derived from CT, MRI, and other modalities. It provides for the communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data. ORS Visual, which is available in 32 and 64-bit versions, can be installed on a standard personal computer running the Windows operating system with the Microsoft ActiveX component and suitable graphics hardware. Available functions include DICOM communication, display of 2D images in orthogonal and oblique planes, computation and display of rendered 3D images and maximum intensity projections (MIPs), and 2D and 3D image measurements. The user interface follows typical clinical workflow patterns that include searching for patient data, reviewing and analyzing digital images, and reporting findings. The user controls these functions with normal mouse-click conventions, a system of context-based tools, and on-screen prompts. A standard layout for image display, navigation, and information is used throughout the application. ORS Visual also offers users two separate add-on modules to address specific vascular clinical functionalities: Vessel Analysis, an add-on solution for vascular analysis and stent-graft planning of CTA studies, and Autoplaque, a cardiac plaque and lesion quantification tool.
Object Research Systems (ORS) Inc
ORS-VISU-0105
In Commercial Distribution

  • B332VISU0105 ()


  • Radiological PACS software

Autoplaque for ORS Visual - B332VIAP0100

Autoplaque is a post-processing add-on module for ORS Visual that provides automated quantification of calcified and non-calcified plaque lesions in coronary arteries from contrasted coronary CT angiographic studies for the evaluation of cardiovascular disease. Users can automatically segment the section of the coronary artery of interest, or manually input the centerline, to initiate a detailed and robust plaque lesion analysis routine. Analysis by Autoplaque provides biometric information that includes calcified plaque volume, non-calcified plaque volume with possible separation into low and high density non-calcified plaques, stenosis percentage, remodeling index, plaque length measurement, and proximal, distal, and stenosis diameters. If the Autoplaque add-on is used to analyze more than one coronary artery section, the additional parameters of total non-calcified plaque volume, total low density plaque volume, total calcified plaque volume, maximum remodeling index, maximum stenosis percentage, and the maximum plaque length will also be available. ORS Visual is a proprietary software application developed by Object Research Systems (ORS) Inc. that can be is used for the display and 3D visualization of medical image data derived from CT, MRI, and other modalities. It provides for the communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data. ORS Visual, which is available in 32 and 64-bit versions, can be installed on a standard personal computer running the Windows operating system with the Microsoft ActiveX component and suitable graphics hardware.
Object Research Systems (ORS) Inc
ORS-VISU-AP01
In Commercial Distribution

  • B332VIAP0100 ()


  • Radiological PACS software

SICAT SUITE - D776SUITEV200

No Description
SiCAT GmbH & Co. KG
V2.0
Not in Commercial Distribution

  • D776SUITEV200 ()


  • Radiological PACS software

SICAT SUITE - D776SUITEV20

No Description
SiCAT GmbH & Co. KG
V2.0
Not in Commercial Distribution

  • D776SUITEV20 ()


  • Radiological PACS software

SICAT IMPLANT - D776IMPLANTV20400

No Description
SiCAT GmbH & Co. KG
V2.0.40
In Commercial Distribution

  • D776IMPLANTV20400 ()


  • Radiological PACS software

SICAT IMPLANT - D776IMPLANTV200

No Description
SiCAT GmbH & Co. KG
V2.0
Not in Commercial Distribution

  • D776IMPLANTV200 ()


  • Radiological PACS software

SICAT IMPLANT - D776IMPLANTV150

No Description
SiCAT GmbH & Co. KG
V1.5
Not in Commercial Distribution

  • D776IMPLANTV150 ()


  • Radiological PACS software

SICAT Implant - D776IMPLANTV15

No Description
SiCAT GmbH & Co. KG
V1.5
Not in Commercial Distribution

  • D776IMPLANTV15 ()


  • Radiological PACS software

GALILEOS Implant - D776GIV1920

No Description
SiCAT GmbH & Co. KG
1.9.2
Not in Commercial Distribution

  • D776GIV1920 ()
6143205

  • Radiological PACS software

SICAT FUNCTION - D776FUNCTIONV20400

No Description
SiCAT GmbH & Co. KG
V2.0.40
In Commercial Distribution

  • D776FUNCTIONV20400 ()


  • Radiological PACS software

SICAT FUNCTION - D776FUNCTIONV200

No Description
SiCAT GmbH & Co. KG
V2.0
Not in Commercial Distribution

  • D776FUNCTIONV200 ()


  • Radiological PACS software

SICAT FUNCTION - D776FUNCTIONV20

No Description
SiCAT GmbH & Co. KG
V2.0
Not in Commercial Distribution

  • D776FUNCTIONV20 ()


  • Radiological PACS software

SICAT ENDO - D776ENDOV20400

No Description
SiCAT GmbH & Co. KG
V2.0.40
In Commercial Distribution

  • D776ENDOV20400 ()


  • Radiological PACS software

SICAT ENDO - D776ENDOV200

No Description
SiCAT GmbH & Co. KG
V2.0
Not in Commercial Distribution

  • D776ENDOV200 ()


  • Radiological PACS software

SICAT ENDO - D776ENDOV20

No Description
SiCAT GmbH & Co. KG
V2.0
Not in Commercial Distribution

  • D776ENDOV20 ()


  • Radiological PACS software

SICAT Air - D776AIRV20400

No Description
SiCAT GmbH & Co. KG
2.0.40
In Commercial Distribution

  • D776AIRV20400 ()


  • Radiological PACS software

SICAT Air - D776AIRV200

No Description
SiCAT GmbH & Co. KG
2.0
Not in Commercial Distribution

  • D776AIRV200 ()


  • Radiological PACS software

SICAT Endo - D77666224630

Radiological Visualization Software for Diagnosis and Dental Treatment Planning
SiCAT GmbH & Co. KG
6622463
Not in Commercial Distribution

  • D77666224630 ()
6622463

  • Radiological PACS software

SurgicalPreview - B642SURGICALPREVIEW2400

SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview enables assessment and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. It provides techniques to assess the feasibility of endovascular procedures. SurgicalPreview also allows for the ability to simulate the placement and deployment of neurointerventional devices. SurgicalPreview can reconstruct 2D scan slices into comprehensive 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. The software does not provide diagnostic information nor does it determine recommended medical care. The clinician receiving the images from the software retains the responsibility for interpreting and validating all information and making all treatment decisions using standard practices.
ENDOVANTAGE LLC
2.4.0
In Commercial Distribution

SURGICALPREVIEW240

  • Vascular modelling software

SurgicalPreview - B642SURGICALPREVIEW2300

SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview enables assessment and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. It provides techniques to assess the feasibility of endovascular procedures. SurgicalPreview also allows for the ability to simulate the placement and deployment of neurointerventional devices. SurgicalPreview can reconstruct 2D scan slices into comprehensive 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. The software does not provide diagnostic information nor does it determine recommended medical care. The clinician receiving the images from the software retains the responsibility for interpreting and validating all information and making all treatment decisions using standard practices.
ENDOVANTAGE LLC
2.3.0
In Commercial Distribution

SURGICALPREVIEW230

  • Vascular modelling software

SurgicalPreview - B642SURGICALPREVIEW2200

Device Description (max 2000 characters): SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview enables assessment and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. It provides techniques to assess the feasibility of endovascular procedures. SurgicalPreview also allows for the ability to simulate the placement and deployment of neurointerventional devices. SurgicalPreview can reconstruct 2D scan slices into comprehensive 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. The software does not provide diagnostic information nor does it determine recommended medical care. The clinician receiving the images from the software retains the responsibility for interpreting and validating all information and making all treatment decisions using standard practices.
ENDOVANTAGE LLC
2.2.0
In Commercial Distribution

SURGICALPREVIEW220

  • Vascular modelling software

SurgicalPreview - B642SURGICALPREVIEW2100

SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview enables assessment and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. It provides techniques to assess the feasibility of endovascular procedures. SurgicalPreview also allows for the ability to simulate the placement and deployment of neurointerventional devices. SurgicalPreview can reconstruct 2D scan slices into comprehensive 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. The software does not provide diagnostic information nor does it determine recommended medical care. The clinician receiving the images from the software retains the responsibility for interpreting and validating all information and making all treatment decisions using standard practices.
ENDOVANTAGE LLC
2.1.0
In Commercial Distribution

  • B642SURGICALPREVIEW2100 ()
SURGICALPREVIEW210

  • Vascular modelling software

SurgicalPreview - B642SURGICALPREVIEW1200

SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview enables assessment and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. It provides techniques to assess the feasibility of endovascular procedures. SurgicalPreview also allows for the ability to simulate the placement and deployment of neurointerventional devices. SurgicalPreview can reconstruct 2D scan slices into comprehensive 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. The software does not provide diagnostic information nor does it determine recommended medical care. The clinician receiving the images from the software retains the responsibility for interpreting and validating all information and making all treatment decisions using standard practices.
ENDOVANTAGE LLC
1.2.0
In Commercial Distribution

  • B642SURGICALPREVIEW1200 ()
SURGICALPREVIEW120

  • Vascular modelling software

SurgicalPreview - B642SURGICALPREVIEW1100

SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview enables assessment and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. It provides techniques to assess the feasibility of endovascular procedures. SurgicalPreview also allows for the ability to simulate the placement and deployment of neurointerventional devices. SurgicalPreview can reconstruct 2D scan slices into comprehensive 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. The software does not provide diagnostic information nor does it determine recommended medical care. The clinician receiving the images from the software retains the responsibility for interpreting and validating all information and making all treatment decisions using standard practices.
ENDOVANTAGE LLC
1.1.0
In Commercial Distribution

  • B642SURGICALPREVIEW1100 ()
SURGICALPREVIEW110

  • Vascular modelling software

SurgicalPreview - B642SURGICALPREVIEW100

SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview enables assessment and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. It provides techniques to assess the feasibility of endovascular procedures. SurgicalPreview also allows for the ability to simulate the placement and deployment of neurointerventional devices. SurgicalPreview can reconstruct 2D scan slices into comprehensive 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. The software does not provide diagnostic information nor does it determine recommended medical care. The clinician receiving the images from the software retains the responsibility for interpreting and validating all information and making all treatment decisions using standard practices.
ENDOVANTAGE LLC
1.0
In Commercial Distribution

  • B642SURGICALPREVIEW100 ()
SURGICALPREVIEW10

  • Vascular modelling software

Core Cognitive Evaluation - B626200050

No Description
Linus Health, Inc.
20005
In Commercial Distribution

  • B626200050 ()
20005

  • Cognitive assessment software

Research Platform - B626200020

No Description
Linus Health, Inc.
20002
Not in Commercial Distribution

  • B626200020 ()


  • Cognitive assessment software

Core Cognitive Evaluation - B626200010

Core Cognitive Evaluation is a non-invasive test that assess possible cognitive impairment. It is intended to be used by medical professionals qualified to interpret results of a cognitive assessment.
Linus Health, Inc.
20001
Not in Commercial Distribution

  • B626200010 ()
20001

  • Cognitive assessment software

Rapid - B761RAPID510

No Description
Ischemaview, Inc.
5.1
In Commercial Distribution

  • B761RAPID510 ()
Rapid 5.1

  • Radiological PACS software

RAPID - B761RAPID49101

Rapid
Ischemaview, Inc.
4.9.1
In Commercial Distribution

  • B761RAPID49101 ()
Rapid

  • Radiological PACS software

Rapid - B761R591

Rapid System Update
Ischemaview, Inc.
5.9
In Commercial Distribution

  • B761R591 ()


  • Radiological PACS software

Rapid - B761R5711

Rapid System Update
Ischemaview, Inc.
5.7.1
In Commercial Distribution

  • B761R5711 ()
Rapid

  • Radiological PACS software

Rapid - B7671R522

Rapid System Update
Ischemaview, Inc.
5.2.2
In Commercial Distribution

  • B7671R522 ()
Rapid

  • Radiological PACS software

Rapid - B7671R521

No Description
Ischemaview, Inc.
5.2.2
In Commercial Distribution

  • B7671R521 ()
Rapid

  • Radiological PACS software

Rapid - B7671R520

No Description
Ischemaview, Inc.
5.2.0
In Commercial Distribution

  • B7671R520 ()
Rapid

  • Radiological PACS software

Rapid - B7671R512

No Description
Ischemaview, Inc.
5.1.2
In Commercial Distribution

  • B7671R512 ()
Rapid

  • Radiological PACS software

Rapid - B7671R511

No Description
Ischemaview, Inc.
5.1.1
In Commercial Distribution

  • B7671R511 ()
Rapid

  • Radiological PACS software
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