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ImageGrid Radiology Viewer System is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations.
Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
CANDELIS, INC.
IG-10H
In Commercial Distribution
- B193IG10H0 ()
- Radiological PACS software
ImageGrid Radiology Viewer System is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations.
Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
CANDELIS, INC.
IG-10B-DR
In Commercial Distribution
- B193IG10BDR0 ()
- Radiological PACS software
ImageGrid Radiology Viewer System is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations.
Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
CANDELIS, INC.
IG-10B
In Commercial Distribution
- B193IG10B0 ()
- Radiological PACS software
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 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 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
The ImageGrid® PACS is a software system intended for professional use only, by prescription in United States. Diagnosis is not performed by the software but by Radiologists, Clinicians and or referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
ImageGrid® is a software device and server that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). The device does not contact the patient, nor does it control any life sustaining devices.
Images (including mammography) and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor of sufficient resolution and which meets other technical specifications reviewed and accepted by the FDA.
ImageGrid® MammoTech Viewer, ImageGrid® Referring Physician Viewer, ASTRA® Lite, ASTRA® Plus and ASTRA® Mobile must not be used for primary image interpretation.
CANDELIS, INC.
IG-UHP-R1H-R-X
In Commercial Distribution
- B193IGUHPR1HRX0 ()
- Radiological PACS software
The ImageGrid® PACS is a software system intended for professional use only, by prescription in United States. Diagnosis is not performed by the software but by Radiologists, Clinicians and or referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
ImageGrid® is a software device and server that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). The device does not contact the patient, nor does it control any life sustaining devices.
Images (including mammography) and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor of sufficient resolution and which meets other technical specifications reviewed and accepted by the FDA.
ImageGrid® MammoTech Viewer, ImageGrid® Referring Physician Viewer, ASTRA® Lite, ASTRA® Plus and ASTRA® Mobile must not be used for primary image interpretation.
CANDELIS, INC.
IG-UHP-R1H-R-SAAS-X
In Commercial Distribution
- B193IGUHPR1HRSAASX0 ()
- Radiological PACS software
The ImageGrid® PACS is a software system intended for professional use only, by prescription in United States. Diagnosis is not performed by the software but by Radiologists, Clinicians and or referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
ImageGrid® is a software device and server that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). The device does not contact the patient, nor does it control any life sustaining devices.
Images (including mammography) and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor of sufficient resolution and which meets other technical specifications reviewed and accepted by the FDA.
ImageGrid® MammoTech Viewer, ImageGrid® Referring Physician Viewer, ASTRA® Lite, ASTRA® Plus and ASTRA® Mobile must not be used for primary image interpretation.
CANDELIS, INC.
IG-UHP-R1H-R-SAAS
In Commercial Distribution
- B193IGUHPR1HRSAAS0 ()
- Radiological PACS software
The ImageGrid® PACS is a software system intended for professional use only, by prescription in United States. Diagnosis is not performed by the software but by Radiologists, Clinicians and or referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
ImageGrid® is a software device and server that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). The device does not contact the patient, nor does it control any life sustaining devices.
Images (including mammography) and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor of sufficient resolution and which meets other technical specifications reviewed and accepted by the FDA.
ImageGrid® MammoTech Viewer, ImageGrid® Referring Physician Viewer, ASTRA® Lite, ASTRA® Plus and ASTRA® Mobile must not be used for primary image interpretation.
CANDELIS, INC.
IG-UHP-R1H-R
In Commercial Distribution
- B193IGUHPR1HR0 ()
- Radiological PACS software