Blue Sky Plan Software

The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.The Vitrea Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:• Retrieve image data over the network via DICOM• Display of images in dedicated protocols which are automatically adapted based on exam type• Select images for closer examination from a gallery of 2D or 3D views• Interactively manipulate an image in real-time to visualize anatomy and pathology• Annotate, measure, and record selected views• Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device• Retrieve reports that are archived on a Web server

The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.The Vitrea Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:• Retrieve image data over the network via DICOM• Display of images in dedicated protocols which are automatically adapted based on exam type• Select images for closer examination from a gallery of 2D or 3D views• Interactively manipulate an image in real-time to visualize anatomy and pathology• Annotate, measure, and record selected views• Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device• Retrieve reports that are archived on a Web server

The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.The Vitrea Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:• Retrieve image data over the network via DICOM• Display of images in dedicated protocols which are automatically adapted based on exam type• Select images for closer examination from a gallery of 2D or 3D views• Interactively manipulate an image in real-time to visualize anatomy and pathology• Annotate, measure, and record selected views• Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device• Retrieve reports that are archived on a Web server

The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.The Vitrea Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:• Retrieve image data over the network via DICOM• Display of images in dedicated protocols which are automatically adapted based on exam type• Select images for closer examination from a gallery of 2D or 3D views• Interactively manipulate an image in real-time to visualize anatomy and pathology• Annotate, measure, and record selected views• Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device• Retrieve reports that are archived on a Web server

The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.The Vitrea Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:• Retrieve image data over the network via DICOM• Display of images in dedicated protocols which are automatically adapted based on exam type• Select images for closer examination from a gallery of 2D or 3D views• Interactively manipulate an image in real-time to visualize anatomy and pathology• Annotate, measure, and record selected views• Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device• Retrieve reports that are archived on a Web server

The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.The Vitrea Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:• Retrieve image data over the network via DICOM• Display of images in dedicated protocols which are automatically adapted based on exam type• Select images for closer examination from a gallery of 2D or 3D views• Interactively manipulate an image in real-time to visualize anatomy and pathology• Annotate, measure, and record selected views• Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device• Retrieve reports that are archived on a Web server

The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.The Vitrea Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:• Retrieve image data over the network via DICOM• Display of images in dedicated protocols which are automatically adapted based on exam type• Select images for closer examination from a gallery of 2D or 3D views• Interactively manipulate an image in real-time to visualize anatomy and pathology• Annotate, measure, and record selected views• Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device• Retrieve reports that are archived on a Web server

The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.The Vitrea Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:• Retrieve image data over the network via DICOM• Display of images in dedicated protocols which are automatically adapted based on exam type• Select images for closer examination from a gallery of 2D or 3D views• Interactively manipulate an image in real-time to visualize anatomy and pathology• Annotate, measure, and record selected views• Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device• Retrieve reports that are archived on a Web server

TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.

TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning.

TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning.

TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning.

TIMS 500 S connects to all analog, digital and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive.

TIMS 500 S connects to all analog, digital and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive.

TIMS 2000 FEES connects to all analog, digital and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities.

TIMS 2000 FEES connects to all analog, digital and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities.

TIMS 2000 FEES-L connects to all analog, digital and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities.

TIMS 2000 FEES-L connects to all analog, digital and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities.

TIMS 2000 FEES-L connects to all analog, digital and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities.

MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE 3DTI BUNDLE

MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE 3DTI BUNDLE

MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE 3DTI AND TITANIUM HYBRID GUIDES BUNDLE

MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT W/ ACCUPLATE 3DTI AND TITANIUM GUIDES BUNDLE

MIDFACE RECONSTURCTION, SURGICAL PLANNING KIT W/ ACCUPLATE 3DTI AND TITANIUM HYBRID GUIDES BUNDLE

MediView single sterile Registration Marker kit for use with XR90.

MediView XR90 single ultrasound probe bracket for use with GE C1-5-RS transducers.

Electromagnetic Field Generator Mounting Brackets (Left) for use with the MediView XR90 system.

Electromagnetic Field Generator Mounting Brackets (Right) for use with the MediView XR90 system.

MediView Triangle Template Kit for use with the XR90 system.

The Medstrat Joints system is intended to enable the communication, storage, viewing, and manipulation of diagnostic medical images and data. The Joints system can show images on workstations locally and/or across computer networks at widely distributed locations. The Joints software is intended for assisting healthcare professionals in preoperative planning and postoperative evaluation of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and positioning the templates. The typical Joints users are trained professionals such as orthopedic surgeons, referring and collaborating physicians, and authorized medical professionals.It is the user's responsibility to bear in mind the display monitor's quality, ambient light conditions, and the tradeoff between image compression ratio and clinical effectiveness for specific image study indications.

The Medstrat Joints system is intended to enable the communication, storage, viewing, and manipulation of diagnostic medical images and data. The Joints system can show images on workstations locally and/or across computer networks at widely distributed locations. The Joints software is intended for assisting healthcare professionals in preoperative planning and postoperative evaluation of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and positioning the templates. The typical Joints users are trained professionals such as orthopedic surgeons, referring and collaborating physicians, and authorized medical professionals.It is the user's responsibility to bear in mind the display monitor's quality, ambient light conditions, and the tradeoff between image compression ratio and clinical effectiveness for specific image study indications.

The Medstrat Joints system is intended to enable the communication, storage, viewing, and manipulation of diagnostic medical images and data. The Joints system can show images on workstations locally and/or across computer networks at widely distributed locations. The Joints software is intended for assisting healthcare professionals in preoperative planning and postoperative evaluation of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and positioning the templates. The typical Joints users are trained professionals such as orthopedic surgeons, referring and collaborating physicians, and authorized medical professionals.It is the user's responsibility to bear in mind the display monitor's quality, ambient light conditions, and the tradeoff between image compression ratio and clinical effectiveness for specific image study indications.

The Medstrat Joints system is intended to enable the communication, storage, viewing, and manipulation of diagnostic medical images and data. The Joints system can show images on workstations locally and/or across computer networks at widely distributed locations. The Joints software is intended for assisting healthcare professionals in preoperative planning and postoperative evaluation of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and positioning the templates. The typical Joints users are trained professionals such as orthopedic surgeons, referring and collaborating physicians, and authorized medical professionals.It is the user's responsibility to bear in mind the display monitor's quality, ambient light conditions, and the tradeoff between image compression ratio and clinical effectiveness for specific image study indications.

The Medstrat Joints system is intended to enable the communication, storage, viewing, and manipulation of diagnostic medical images and data. The Joints system can show images on workstations locally and/or across computer networks at widely distributed locations. The Joints software is intended for assisting healthcare professionals in preoperative planning and postoperative evaluation of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and positioning the templates. The typical Joints users are trained professionals such as orthopedic surgeons, referring and collaborating physicians, and authorized medical professionals.It is the user's responsibility to bear in mind the display monitor's quality, ambient light conditions, and the tradeoff between image compression ratio and clinical effectiveness for specific image study indications.

The Medstrat Joints system is intended to enable the communication, storage, viewing, and manipulation of diagnostic medical images and data. The Joints system can show images on workstations locally and/or across computer networks at widely distributed locations. The Joints software is intended for assisting healthcare professionals in preoperative planning and postoperative evaluation of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and positioning the templates. The typical Joints users are trained professionals such as orthopedic surgeons, referring and collaborating physicians, and authorized medical professionals.It is the user's responsibility to bear in mind the display monitor's quality, ambient light conditions, and the tradeoff between image compression ratio and clinical effectiveness for specific image study indications.

Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system. The Merge Cardio system is intended to allow authorized health care professionals the ability to import, export, review, analyze, quantify, report and manage digital cardiovascular images, documents, and data related to cardiology. The study list supports workflow management by providing a robust study list with configurable informational columns supporting navigation, current study and reporting status, and prior study availability and relevancy. The system offers standard image controls such as brightness, contrast, zoom, and cine playback controls; as well modality specific tools such as R-wave sync and frame rate sync. The system allows users to review images, annotate images, perform digital subtraction on XA images, perform quantitative measurements on images (based on modality and anatomy including quantitative coronary analysis, left ventricular analysis, distance, angle, velocity, slope, area, velocity time integral, and volume), derive US measurements, and generate clinical reports. The system provides the ability to create clinical reports for Adult Echo, Pediatric Echo, Vascular US, Nuclear Medicine, Cath/Peripheral Invasive, Electrophysiology, Cardiac CT, and Cardiac MR. Merge Cardio runs on standard information technology hardware and software, using standard technology operating systems and user interfaces. Communication and data exchange are done using standard protocols.

A medical imaging software package that provides imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging, and cardiac imaging.

AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one of the following digital x-ray receptor panels: AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717 G4. The solid state imaging receptors can be used in wireless or tethered configuration. The indications for use remain unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the available selection of (previously cleared) digital panels. Each system consists of the following items: Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITV+ Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt We supply: Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K210919.We are supplying rebranded versions of the reference devices coupled with the AccuVue software cleared in our predicate K210919.

AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one of the following digital x-ray receptor panels: AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717 G4. The solid state imaging receptors can be used in wireless or tethered configuration. The indications for use remain unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the available selection of (previously cleared) digital panels. Each system consists of the following items: Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITV+ Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt We supply: Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K210919. We are supplying rebranded versions of the reference devices coupled with the AccuVue software cleared in our predicate K210919.

AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one of the following digital x-ray receptor panels: AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717 G4. The solid state imaging receptors can be used in wireless or tethered configuration. The indications for use remain unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the available selection of (previously cleared) digital panels. Each system consists of the following items: Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITV+ Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt We supply: Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K210919. We are supplying rebranded versions of the reference devices coupled with the AccuVue software cleared in our predicate K210919.

Data Manager PC

HMD

HMD Custom Lens Insert