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Found 4 results
510(k) Data Aggregation
K Number
K082144Device Name
AMICAS PACS, VERSION 6.0
Manufacturer
AMICAS, INC.
Date Cleared
2008-09-05
(37 days)
Product Code
LLZ, REG
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
AMICAS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AMICAS PACS 6.0 is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, to include Digital Mammography. AMICAS PACS 6.0 receives images acquired from DICOM-compliant medical imaging systems, data from FDA-cleared Computer-Aided Detection systems and other FDA-cleared Image processing systems.
AMICAS PACS 6.0 imports images and render said images, upon request, within the viewer component utilizing both lossless (reversible) and lossy (irreversible) compression. To support the diagnostic interpretation of Mammography studies, AMICAS PACS 6.0 will display the full fidelity DICOM image in a non-compressed format. Images will be rendered with patient and clinical information clearly displayed as part of the DICOM Overlay as required by MQSA, on monitors cleared by FDA for use in Digital Mammography. Lossy compressed mammography images and digitized film screen images must not be used for the purpose of primary diagnosis. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Within AMICAS PACS 6.0, the AMICAS Real Time Worklist offers real-time status of radiology activity and provides customizable workflow management capabilities. Communication of critical results is facilitated and documented through optional, and configurable, components within the Real Time Worklist.
AMICAS PACS 6.0 also offers the Patient Dashboard which provides a single view of all patient data, both imaging and non-imaging.
AMICAS Reach is an optional component within AMICAS PACS 6.0 which provides clinicians secure, proactive communication and access to clinical reports and images.
Order and Report information generated by HIS/RIS and report creation systems are received and displayed in PACS via the transmission of HL7 messaging. For this data, AMICAS PACS 6.0 is not the creator, but instead the downstream recipient which relies on the validity of data from said systems.
AMICAS PACS 6.0 must be installed on suitable, commercial-standard hardware. It is the user's responsibility to ensure monitor quality, ambient light conditions and image compression ratios are consistent with the clinical application.
Device Description
AMICAS PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images. Typical users of AMICAS PACS 6.0 are radiologists, technologists and clinicians.
AMICAS PACS 6.0 is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, to include Digital Mammography. AMICAS PACS 6.0 receives images acquired from DICOM-compliant medical imaging systems, data from FDA-cleared Computer-Aided Detection systems and other FDA-cleared Image processing systems.
AMICAS PACS 6.0 imports images and render said images, upon request, within the viewer component utilizing both lossless (reversible) and lossy (irreversible) compression.
To support the diagnostic interpretation of Mammography studies. AMICAS PACS 6.0 will display the full fidelity DICOM image in a non-compressed format. Images will be rendered with patient and clinical information clearly displayed as part of the DICOM Overlay as required by MQSA, on monitors cleared by FDA for use in Digital Mammography. Lossy compressed mammography images and digitized film screen images must not be used for the purpose of primary diagnosis. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA,
Within AMICAS PACS 6.0, the AMICAS Real Time Worklist offers real-time status of radiology activity and provides customizable workflow management capabilities. Communication of critical results is facilitated and documented through optional, and configurable, components within the Real Time Worklist.
AMICAS PACS 6.0 also offers the Patient Dashboard which provides a single view of all patient data, both imaging and non-imaging.
AMICAS Reach is an optional component within AMICAS PACS 6.0 which provides clinicians secure, proactive communication and access to clinical reports and images.
Order and Report information generated by HIS/RIS and report creation systems are received and displayed in PACS via the transmission of HL7 messaging. For this data, AMICAS PACS 6.0 is not the creator, but instead the downstream recipient which relies on the validity of data from said systems.
AMICAS PACS 6.0 must be installed on suitable, commercial-standard hardware. It is the user's responsibility to ensure monitor quality, ambient light conditions and image compression ratios are consistent with the clinical application.
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K Number
K073526Device Name
AMICAS VISION SERIES PACS, MODEL 5.5
Manufacturer
AMICAS, INC.
Date Cleared
2008-03-12
(86 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
AMICAS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vision Series PACS 5.5 is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, to include Digital Mammography. Vision Series PACS receives images acquired from DICOM-compliant medical imaging systems, data from FDA-cleared Computer-Aided Detection systems and other FDA-cleared Image processing systems.
Vision Series PACS imports images and render said images, upon request, within the AMICAS LightBeam Diagnostic Workstation utilizing both lossless (reversible) and lossy (irreversible) compression.
To support the diagnostic interpretation of Mammography studies, Vision Series PACS will display the full fidelity DICOM image in a non-compressed format. Images will be rendered with patient and clinical information clearly displayed as part of the DICOM Overlay as required by MQSA, on monitors cleared by FDA for use in Digital Mammography. Lossy compressed mammography images and digitized film screen images should not be used for the purpose of primary diagnosis. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Within Vision Series PACS 5.5, the AMICAS Real Time Worklist offers real-time status of radiology activity and provides customizable workflow management capabilities. Communication of critical results is facilitated and documented through optional, and configurable, components within the Real Time Worklist.
Vision Reach is an optional component within the PACS 5.5 offering which provides clinicians secure, proactive communication and access to clinical reports and images.
Order and Report information generated by HIS/RIS and report creation systems are received and displayed in PACS via the transmission of HL7 messaging. For this data. AMICAS is not the creator, but instead the downstream recipient which relies on the validity of data from said systems.
Vision Series PACS must be installed on suitable, commercial-standard hardware. It is the user's responsibility to ensure monitor quality, ambient light conditions and image compression ratios are consistent with the clinical application.
Device Description
AMICAS Vision Series PACS 5.5 is software intended to create and display twodimensional and three-dimensional images of anatomy from a series of digitally acquired images.
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K Number
K062477Device Name
AMICAS VISION SERIES PACS, MODEL 4.3
Manufacturer
AMICAS, INC.
Date Cleared
2006-10-27
(64 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
AMICAS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vision Series PACS 4.3 is designed and marketed for soft copy reading, communication, printing and storage of studies produced by digital modalities, to include Digital Mammography.
Vision Series PACS receives images acquired from DICOM-compliant medical imaging systems, data from FDA-cleared Computer-Aided Detection systems and other FDA-cleared Image processing systems.
Vision Series PACS imports images and render said images, upon request, within the AMICAS LightBeam Diagnostic Workstation utilizing both lossless (reversible) and lossy (irreversible) compression.
To support the diagnostic interpretation of Mammography studies, Vision Series PACS will display the full fidelity DICOM image in a non-compressed format. Images will be rendered with patient and clinical information clearly displayed as part of the DICOM Overlay as required by MQSA, on monitors cleared by FDA for use in Digital Mammography. Lossy compressed mammography images and digitized film screen images should not be used for the purpose of primary diagnosis. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Vision Series PACS formats and delivers images over a network to a FDA-cleared DICOM printer as requested and defined by the user.
Vision Series PACS must be installed on suitable, commercial-standard hardware. It is the user's responsibility to ensure monitor quality, ambient light conditions and image compression ratios are consistent with the clinical application.
Device Description
AMICAS Vision Series PACS 4.3 is software intended to create and display twodimensional and three-dimensional images of anatomy from a series of digitally acquired images.
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K Number
K022970Device Name
AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0
Manufacturer
AMICAS, INC.
Date Cleared
2002-11-22
(77 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
AMICAS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AMICAS Diagnostic Workstation (ADW) is software intended for viewing and diagnostic interpretation of images acquired from CT, MR, CR, DR, US and other DICOM-compliant medical imaging systems when installed on suitable commercial-standard hardware. The ADW receives imaging studies over a network from AMICAS servers or directly from CD with images utilizing both lossless (reversible) and lossy (irreversible) compression. It is the user's responsibility to ensure that monitor quality, ambient light conditions and image compression ratios are consistent with the clinical application.
Device Description
AMICAS Light Beam Workstation (ALBW) is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
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