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510(k) Data Aggregation
K Number
K030728Device Name
FYRELINK VL
Manufacturer
MPACS, LLC.
Date Cleared
2003-05-23
(77 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
MPACS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for use when there is a need to convert endoscopic and microscopic surgical video to a digital video format for subsequent review and archiving. This device will also transfer the digital video over digital networks and/or digital communication lines.
Device Description
fyreLINK VL (formerly echoLINK) now provides the endoscopy and surgical market a real-time solution for dealing with video data in a complete image management system. There are three major components that make up the fyreLINK VL product line; an image acquisition unit, a review station (either the fyreLINK station or a third party product), and a DVD library system or other archive device. The telemedicine system uses the same components except for the DVD library system. Appendix D shows an example of how an image acquisition unit can be arranged to provide a particular customer solution.
The fyreLINK VL Image Acquisition Unit (IAU) is the key component of the fyreLINK VL device. It uses a hardware video converter to convert analog video coming from a surgical video system to streaming digital video in real time. This streaming digital video is then compressed using MPEG 2 technology and stored on its local hard drive as a MPEG2 file. The IAU can store up to 1000 minutes of digital video data on its internal hard disk. The data is available for immediate review on the IAU, or can be exported to another application or another workstation or archive. Each acquired recording is an individual file. Exams can consist of a single continuous recording of the entire procedure, or a collection of shorter recordings of areas of interest. Still images may also be captured and saved as bitmap or JPEG files. The IAU is built on a Windows 2000 platform, and is network-ready for transferring patient data to a local or central archive system and/or to a physician's review station. The IAU's compact size allows it to be a direct replacement for existing VCR's used in endoscopic and microscopic surgical procedures. The IAU platform can consist of either a laptop or desktop type computer. The device has an electronic report generator that will allow the user to enter exam information as part of a paperless reporting system. The IAU, when configured as part of a WAN environment, can be a part of a remote access telemedicine system. The IAU is controlled by MPACS proprietary software.
fyreLINK VL offers two review station solutions. Acquired images can be reviewed at the IAU, or the image files can be exported for use with another application. THE REVIEW FUNCTION OF FYRELINK VL SOFTWARE LABELS ALL RECALLED IMAGES WITH THE TYPE OF COMPRESSION USED AND THE COMPRESSION RATIO.
fyreLINK VL used in a network environment can integrate with a mass archive solution already in place. As an alternative, the IAU includes a DVD recorder built in, to permit immediate local archival of endoscopic or microscopic surgical procedures.
MPACS can supply network solutions for integrating the fyreLINK VL components. In a network configuration, the image acquisition unit moves patient studies directly to a server. The networked review station is able to review both on-line and near-line studies. Network solutions can also include telecommunication links such as T1, DSL, and cable modem connections for telemedicine.
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K Number
K030242Device Name
FYRELINK
Manufacturer
MPACS, LLC.
Date Cleared
2003-03-10
(46 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
MPACS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for use by health care professionals trained in the field of echocardiography or medical ultrasound. It is to be used when there is a need to convert ultrasound video to a digital video format for subsequent review and archiving. This device is also intended for use in transferring ultrasound images over digital networks and/or digital communication lines.
Device Description
fyreLINK (formerly echoLINK) now provides the cardiology ultrasound market a realtime solution for dealing with EC data, a telecardiology system, a complete image management system, and stress echo acquisition with LV function, M-mode, and Doppler measurements. There are four major components that make up the fyreLINK product line; an image acquisition unit, a review station, a DVD library system, and the networking configuration. The telecardiology system uses the same components except for the DVD library system. Appendix D shows several examples of how these components can be arranged to provide customer solutions.
The fyreLINK image acquisition unit (IAU) is the key component of the fyreLINK device. It uses a hardware video converter to convert analog video coming from the ultrasound machine to streaming digital video in real time. This streaming digital video can then be compressed using MPEG 2 or a lossless compression technique (run-length encoding), and stored on the local hard drive as an MPEG2 or an AVI file. The IAU can store up to 1000 minutes of digital video data on its internal hard disk if MPEG2 compression is used, or 30 minutes if lossless compression is used... The data is available for immediate review on the IAU, or can be exported to another application or another workstation or archive. The IAU employs user-defined protocols for view indexing. Each acquired view is an individual file. The IAU allows the user to place time markers within a view to identify the start of systole (the contraction phase of the heart). This intra-view marking is necessary for stress echo applications. The IAU is built on a Windows 2000 platform, and is network-ready for transferring patient data to a local or central archive system and/or to a physician's review station. The IAU's compact size allows it to be a direct replacement for the ultrasound machine's existing VCR. The IAU platform can consist of either a laptop or desktop type computer. The device has an electronic report generator that will allow the sonographer and physician to enter exam information as part of a paperless reporting system. The IAU, when configured as part of a WAN environment, can be a part of a remote access telecardiology system. The IAU is controlled by MPACS proprietary software.
fyreLINK offers two review station solutions. Acquired images can be reviewed at the IAU, or the image files can be exported for use with another application. THE REVIEW FUNCTION OF FYRELINK SOFTWARE LABELS ALL RECALLED IMAGES WITH THE TYPE OF COMPRESSION USED AND THE COMPRESSION RATIO.
fyreLINK used in a network environment can integrate with a mass archive solution already in place. As an alternative, the IAU includes a CD-R recorder built in, to permit immediate local archival of ultrasound studies. CD-R recorders can also be added to customer review stations.
MPACS will supply network solutions for integrating the fyreLINK components. In a network configuration, the image acquisition unit moves patient studies directly to a server. The review station is able to review both on-line and near-line studies. Network solutions will also include telecommunication links such as T1, ISDN, and modem connections for telecardiology.
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K Number
K980060Device Name
ECHOLINK
Manufacturer
MPACS, LLC.
Date Cleared
1998-02-25
(49 days)
Product Code
LLZ, 92L
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
MPACS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for use by health care professionals trained in the field of echocardiography or medical ultrasound. It is to be used when there is a need to convert ultrasound analog video to a digital video format for subsequent review and archiving. This device is also intended for use in transferring ultrasound images over digital networks and/or digital communication lines.
Device Description
EchoLINK provides a telecardiology system, a complete image management system, and a stress echo acquisition and measurement system. There are four major components that make up the EchoLINK device; an image acquisition unit, a review station, a CDR library system, and the networking components.
The EchoLINK image acquisition unit (IAU) uses MPEG2 technology to convert analog video coming from the ultrasound machine to digital video in real time. The IAU can store up to 130 minutes of digital video data on its internal hard disk or 20 minutes on a removal digital storage device. The data storage format is in standard WindowsNT or DICOM 3. The IAU employs user-defined protocols for view indexing. The IAU allows for the placement of time markers within a view to identify the start and end of systole (necessary for stress echo applications) and allows the user to measure left ventricular function. The IAU is network-ready for transferring patient data to a central CDR library system and/or to a physician's review station. The EchoLINK device has an electronic report generator that allows the sonographer and physician to enter exam information as part of a paperless reporting system.
The EchoLINK device, when equipped with an optional modem or ISDN interface, can be remotely accessed to provide a variety of telecardiology solutions. The device is controlled by MPACS proprietary software.
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