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510(k) Data Aggregation
K Number
K974130Device Name
VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE
Manufacturer
DEJARNETTE RESEARCH SYSTEMS
Date Cleared
1998-01-29
(87 days)
Product Code
LMD
Regulation Number
892.2020Why did this record match?
Applicant Name (Manufacturer) :
DEJARNETTE RESEARCH SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VisiShare Imaging System and/or Software is a digital imaging viewing system that receives digital images and patient demographic information from various imaging sources. The incoming data formats are standard medical image formats, proprietary image formats, and common non-medical image formats. The VisiShare allows the operator to manage, view, retrieve and store images, modify image parameters and annotate image for the purposes of radiological interpretation.
Device Description
The VisiShare Imaging System is designed to accept images from various modalities or digital image networks and allow the operator to view, retrieve, store and manipulate medical images in a variety of formats.
The VisiShare is a modular system that uses network and proprietary interfaces for communication between the modules. Network interfaces enable the various modules to reside on local or remote machines. System is designed for low-end and high-end systems, supporting single or multiple monitor configurations.
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K Number
K973421Device Name
IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE(2100{SIKARUS X86}/(1500{WINDOWS NT}
Manufacturer
DEJARNETTE RESEARCH SYSTEMS
Date Cleared
1997-12-05
(86 days)
Product Code
LMD
Regulation Number
892.2020Why did this record match?
Applicant Name (Manufacturer) :
DEJARNETTE RESEARCH SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Imageshare Computed Radiography Acquisition Station and/or Software is a bi-directional gateway that sends or receives digital images to/from various image sources (including, but not limited to, Fuji CR, Fuji HI-C654, Analogic Corporation's DASM, Computed Radiography or Direct Radiography devices). The incoming data formats may be raw CR data, processed CR data or data formats proprietary to the modality source vendor. The Imageshare Computed Radiography Acquisition Station and/or Software converts the data to DICOM, ACR-NEMA v2.0, SPI format or other proprietary data format and transmits the data to one or more user-specified nodes across a standard, general purpose computing network.
Device Description
The Imageshare Computed Radiography Acquisition and/or Software is designed to operate on a general purpose computer system running an image acquisition software application to receive, reformat and transmit image and demographic information. The system receives the image messages from a Computed Radiography or other image source and routes them automatically through a conversion to a destination based on information contained in the message source, encoded data or data entered or configured by an operator through a user interface. The Imageshare Computed Radiography Acquisition stores the data on its local hard disk until the destination acknowledges the successful transmission. Image delivery is also guaranteed when the Imageshare Computed Radiography Acquisition Station loses power and is restarted.
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K Number
K973422Device Name
LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT])
Manufacturer
DEJARNETTE RESEARCH SYSTEMS
Date Cleared
1997-10-28
(48 days)
Product Code
LMC
Regulation Number
892.2040Why did this record match?
Applicant Name (Manufacturer) :
DEJARNETTE RESEARCH SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lasershare Print Spooler and/or Software is a distributable filming management system that receives digital images and format control data from various image sources (including, but not limited to, CT scanners, MR scanners, Ultrasound systems, R/F units, Computed and Direct Radiography devices, secondary capture devices, imaging gateways, removable storage media or other imaging sources) connected point to point or via networks. The incoming data formats are standard medical imaging formats or proprietary to the modality source vendor. The Lasershare Print Spooler and/or Software allows the operator to manage print job requests, create filming sessions and route image and patient data to one or more laser film printers, thermal dye sublimation and dry printers and other medical imaging print devices.
Device Description
The Lasershare Print Spooler is designed to accept images from various modalities or digital image networks and direct images to one or more medical imaging print devices, providing spooling and queue management facilities. The Lasershare Print Spooler and/or Software is a different model of the current Lasershare Print Spooler and/or Software [predicate device], ported to another operating system. The Lasershare is a modular system that uses network interfaces for communication between the modules. Network interfaces enable the various modules to reside on local or remote machines.
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K Number
K963861Device Name
LASERSHARE PRINT SPOOLER AND/OR SOFTWARE
Manufacturer
DEJARNETTE RESEARCH SYSTEMS
Date Cleared
1996-12-18
(85 days)
Product Code
LMD
Regulation Number
892.2020Why did this record match?
Applicant Name (Manufacturer) :
DEJARNETTE RESEARCH SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lasershare Print Spooler and/or Software is a distributable filming management system that receives digital images and format control data from various image sources (including, but not limited to, CT scanners, MR scanners, Ultrasound systems, R/F units, Computed and Direct Radiography devices, secondary capture devices, imaging gateways, removable storage media or other imaging sources) connected point to point or via networks. The incoming data formats are standard medical imaging formats or proprietary to the modality source vendor. The Lasershare Print Spooler and/or Software allows the operator to manage print job requests, create filming sessions and route image and patient data to one or more laser film printers, thermal dye sublimation and dry printers and other medical imaging print devices.
Device Description
The Lasershare Print Spooler is designed to accept images from various modalities or digital image networks and direct images to one or more medical imaging print devices, providing spooling and queue management facilities. Core technology for the Lasershare Print Spooler is based on, and various software components ported from, the Imageshare 910 Protocol Converter (a predicate device). The Lasershare is a modular system that uses network interfaces for communication between the modules. Network interfaces enable the various modules to reside on local or remote machines. The Lasershare Print Spooler and/or Software is designed to run on off-the-shelf, general purpose computing equipment. The application software is designed for maximum portability across operating systems and hardware platforms. Performance of the application software is primarily a function of network load; secondarily a function of the hardware platform's computational speed and finally the performance of the printer(s). Intrinsic performance of the application does not change significantly as it is ported from one operating system to another.
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K Number
K963592Device Name
IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2 WARP] 1OOO,[SUN/SOLARIS] 2000
Manufacturer
DEJARNETTE RESEARCH SYSTEMS
Date Cleared
1996-11-07
(59 days)
Product Code
LMD
Regulation Number
892.2020Why did this record match?
Applicant Name (Manufacturer) :
DEJARNETTE RESEARCH SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Imageshare Protocol Converting Gateway and/or Software is a uni-directional (or optionally, bi-directional) gateway that receives digital images from various image sources (including, but not limited to, CT scanners, MR scanners, Ultrasound systems, R/F units, Computed and Direct Radiography devices, secondary capture devices, imaging gateways, or other imaging sources), The incoming data formats are DICOM, ACR-NEMA v2.0, SPI (Standard Product Interconnect) or proprietary to the modality source vendor. The Imageshare Protocol Converting Gateway converts them into DICOM, ACR-NEMA v2.0, SPI format or proprietary data format and transmits the data to one or more user-specified nodes across a standard, general purpose computing network.
Device Description
The Imageshare Protocol Converting Gateway is a general purpose computer system running a protocol conversion software application that uses defined configuration to receive, reformat and transmit image and demographic information. The system receives the image messages from a source and routes them automatically them through a conversion to a remote destination based on information contained in both the message source and encoded data. The system requires no user interaction when in operation. The Imageshare Protocol Converting Gateway stores the image data on its local hard disk until the destination application acknowledges the successful transmission. Images that are not delivered to their destination are queued for retransmission until the remote destination confirms receiving the message. This is also true when the Imageshare Protocol Converting Gateway loses power and is restarted.
The Imageshare Protocol Converting Gateway is adaptable to various PACS environments. The configuration can be modified by the system administrator to adapt the Imageshare Protocol Converting Gateway to perform the desired supported conversions.
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K Number
K963594Device Name
IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGITIZER ACQUISITION STATION)
Manufacturer
DEJARNETTE RESEARCH SYSTEMS
Date Cleared
1996-11-07
(59 days)
Product Code
LMD
Regulation Number
892.2020Why did this record match?
Applicant Name (Manufacturer) :
DEJARNETTE RESEARCH SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Imageshare Secondary Capture Acquisition Station and/or Software is a uni-directional gateway that receives digital or analog images from various image sources (including, but not limited to, film digitizers, video signal outputs or print output from imaging modalities, or other imaging sources). The incoming data formats are bitmapped, raster images or proprietary to the modality source vendor. The Imageshare Secondary Capture Acquisition Station and/or Software converts the data to DICOM, ACR-NEMA v2.0, SPI format or other proprietary data format and transmits the data to one or more user-specified nodes across a standard, general purpose computing network.
Device Description
The Imageshare Secondary Capture Acquisition Station is a general purpose computer system running an image acquisition software application to receive, reformat and transmit image and demographic information. The system receives the image messages from a source (film digitizer, video source, ultrasound, print output, etc.) and routes them automatically through a conversion to a destination based on information contained in the message source, encoded data and data entered by an operator through a user interface. The Imageshare Secondary Capture Acquisition Station stores the data on its local hard disk until the destination application acknowledges the successful transmission. Images not delivered to their destination are queved for retransmission until the remote destination confirms receipt of the message. Image delivery is also guaranteed when the Imageshare Secondary Capture Acquisition Station loses power and is restarted.
The Imageshare Secondary Capture Acquisition Station is adaptable to various PACS environments. The configuration can be modified by the system administrator to adapt the Imageshare Secondary Capture Acquisition Station to perform functions specific to the site.
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K Number
K963628Device Name
IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE
Manufacturer
DEJARNETTE RESEARCH SYSTEMS
Date Cleared
1996-11-07
(57 days)
Product Code
LMD
Regulation Number
892.2020Why did this record match?
Applicant Name (Manufacturer) :
DEJARNETTE RESEARCH SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Imageshare Computed Radiography Acquisition Station and/or Software is a uni-directional gateway that receives digital images from various image sources (including, but not limited to, Fuji CR, Fuji HI-C654, Analogic Corporation's DASM, Computed Radiography or Direct Radiography devices). The incoming data formats may be raw CR data, processed CR data or data formats proprietary to the modality source vendor. The Imageshare Computed Radiography Acquisition Station and/or Software converts the data to DICOM, ACR-NEMA v2.0, SPI format or other proprietary data format and transmits the data to one or more user-specified nodes across a standard, general purpose computing network.
Device Description
The Imageshare Computed Radiography Acquisition Station and/or Software is designed 1 operate on a general purpose computer system running an image acquisition software application to receive, reformat and transmit image and demographic information. The system receives the image messages from a Computed Radiography or other image source and routes them automatically through a conversion to a destination based on information contained in the message source, encoded data or data entered by an operator through a user interface. The Imageshare Computed Radiography Acquisition Station stores the data on its local-fard disk until the destination application acknowledges the successful transmission. Image delivery is also guaranteed when the Imageshare Computed Radiography Acquisition Station loses power and is restarted.
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